Information only, not medical advice. Talk to your doctor or pharmacist.

Full list

Approvals

175 approvals (204 source records) dated January 1, 2025 through . Data pulled .

October 2026

Health Canada

Unclassified

MYQORZO

AFICAMTEN 5 MG; AFICAMTEN 10 MG; AFICAMTEN 15 MG; AFICAMTEN 20 MG

Company: CYTOKINETICS, INCORPORATED

Authorization date:

Data pulled:

This DPD record had no therapeutic class in the pull, so the condition is Unclassified.

  • DIN: 02572702, 02572710, 02572729, 02572737
  • Drug code: 107464, 107465, 107466, 107467
  • DPD status: Approved

Health Canada

Unclassified

JASCAYD

NERANDOMILAST 9 MG; NERANDOMILAST 18 MG

Company: BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Authorization date:

Data pulled:

Therapeutic class L04AA61 NERANDOMILAST did not match one condition rule, so the condition is Unclassified.

  • DIN: 02572354, 02572362
  • Drug code: 107431, 107432
  • DPD status: Approved
  • Therapeutic class: L04AA61 NERANDOMILAST

Health Canada

Unclassified

RHAPSIDO

REMIBRUTINIB 25 MG

Company: NOVARTIS PHARMACEUTICALS CANADA INC

Original market date:

Data pulled:

Therapeutic class L04AA60 REMIBRUTINIB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02570076
  • Drug code: 107225
  • DPD status: Marketed
  • Therapeutic class: L04AA60 REMIBRUTINIB

Health Canada

Unclassified

BOEY

TRENIBOTULINUMTOXINE 1400 UNIT

Company: ABBVIE CORPORATION

Original market date:

Data pulled:

Therapeutic class M03AX01 BOTULINUM TOXIN did not match one condition rule, so the condition is Unclassified.

  • DIN: 02569086
  • Drug code: 107135
  • DPD status: Marketed
  • Therapeutic class: M03AX01 BOTULINUM TOXIN

Health Canada

Unclassified

FREHEMGO

DENECIMIG 1.6 MG; DENECIMIG 4 MG; DENECIMIG 9 MG; DENECIMIG 20 MG; DENECIMIG 46 MG

Company: NOVO NORDISK CANADA INC

Authorization date:

Data pulled:

Therapeutic class B02BX OTHER SYSTEMIC HEMOSTATICS did not match one condition rule, so the condition is Unclassified.

  • DIN: 02572095, 02572109, 02572117, 02572125, 02572133
  • Drug code: 107408, 107409, 107410, 107411, 107412
  • DPD status: Approved
  • Therapeutic class: B02BX OTHER SYSTEMIC HEMOSTATICS

September 2026

Health Canada

Unclassified

DAWNZERA

DONIDALORSEN (DONIDALORSEN SODIUM) 80 MG

Company: CELYSTRA PHARMA INC.

Authorization date:

Data pulled:

Therapeutic class B06AC09 DONIDALORSEN did not match one condition rule, so the condition is Unclassified.

  • DIN: 02571943
  • Drug code: 107395
  • DPD status: Approved
  • Therapeutic class: B06AC09 DONIDALORSEN

EMCITATE

TIRATRICOL 350MCG

Sponsor: RARE THYROID

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220963
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET, FOR SUSPENSION
  • Route: ORAL
  • Submission property: Orphan

ATEBRIOZ

ZILURGISERTIB FUMARATE EQ 25MG BASE

Sponsor: MIRUM

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA221198
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

JUVMO · JUVMO (COPACKAGED)

TAVAPADON 15MG; TAVAPADON 5MG; TAVAPADON 10MG; TAVAPADON 0.25MG

Sponsor: ABBVIE

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220415
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Oncology

HERNEXEOS

ZONGERTINIB 60 MG

Company: BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Authorization date:

Data pulled:

Condition mapped from Health Canada ATC L01EH04 ZONGERTINIB.

  • DIN: 02571730
  • Drug code: 107376
  • DPD status: Approved
  • Therapeutic class: L01EH04 ZONGERTINIB

LYRFIGTU

LIRAFUGRATINIB HYDROCHLORIDE EQ 20MG BASE; LIRAFUGRATINIB HYDROCHLORIDE EQ 30MG BASE

Sponsor: ELEVAR

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220425
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL
  • Submission property: Orphan

ONSWIK

INSULIN EFSITORA ALFA-GOBE 1000 UNITS/ML; INSULIN EFSITORA ALFA-GOBE 500 UNITS/ML

Sponsor: ELI LILLY AND CO

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761408
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: SUBCUTANEOUS

Health Canada

Unclassified

BESREMI

ROPEGINTERFERON ALFA-2B 500 MCG

Company: FORUS THERAPEUTICS INC.

Original market date:

Data pulled:

Therapeutic class L03AB15 ROPEGINTERFERON ALFA-2B did not match one condition rule, so the condition is Unclassified.

  • DIN: 02569728
  • Drug code: 107193
  • DPD status: Marketed
  • Therapeutic class: L03AB15 ROPEGINTERFERON ALFA-2B

ISEMBYLD

APITEGROMAB-MSTN 150MG/3ML (50MG/ML)

Sponsor: SCHOLAR ROCK INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761463
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: INJECTION
  • Submission property: Orphan

PIXCLARA

FLORETYROSINE F-18 5-300mCi/ML

Sponsor: TELIX

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA218592
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: INTRAVENOUS
  • Submission property: Orphan

Health Canada

Malaria

AMIVAS-ARTESUNATE

ARTESUNATE 110 MG

Company: AMIVAS IRELAND LTD.

Original market date:

Data pulled:

Condition mapped from Health Canada ATC P01B ANTIMALARIALS.

  • DIN: 02559056
  • Drug code: 106224
  • DPD status: Marketed
  • Therapeutic class: P01B ANTIMALARIALS

ETCAMAH

CAMIZESTRANT 75MG

Sponsor: ASTRAZENECA

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220359
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

ZANVASTRO

ZILGANERSEN SODIUM EQ 56MG BASE/2.8ML (EQ 20MG BASE/ML)

Sponsor: IONIS PHARMS INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220210
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: INTRATHECAL
  • Submission property: Orphan

August 2026

MIMRYLO

RUSFERTIDE ACETATE EQ 54MG BASE/VIAL; RUSFERTIDE ACETATE EQ 28MG BASE/VIAL; RUSFERTIDE ACETATE EQ 9.5MG BASE/VIAL; RUSFERTIDE ACETATE EQ 41MG BASE/VIAL; RUSFERTIDE ACETATE EQ 19MG BASE/VIAL

Sponsor: TAKEDA PHARMS AM

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220605
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: POWDER
  • Route: SUBCUTANEOUS
  • Submission property: Orphan

LISRAYA

BREPOCITINIB TOSYLATE EQ 30MG BASE

Sponsor: PRIOVANT THERAP

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220106
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

RASONQUE

DARAXONRASIB 100MG; DARAXONRASIB 150MG

Sponsor: REVOLUTION MEDICINES

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220910
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

PASATRU

GARETOSMAB-GRTS 300MG/5ML

Sponsor: REGENERON PHARMACEUTICALS, INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761508
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: INTRAVENOUS
  • Submission property: Orphan

TAUKLARIFY

FLORQUINITAU F-18 1-40mCi/ML

Sponsor: CERVEAU LANTHEUS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220496
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: INTRAVENOUS

ZENBEXUS

IBERDOMIDE HYDROCHLORIDE EQ 1MG BASE; IBERDOMIDE HYDROCHLORIDE EQ 0.75MG BASE

Sponsor: BRISTOL MYERS SQUIBB

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA221075
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Oncology

PIMJETMI

PIMICOTINIB (PIMICOTINIB HYDROCHLORIDE) 25 MG

Company: EMD SERONO, A DIVISION OF EMD INC., CANADA

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01X OTHER ANTINEOPLASTIC AGENTS.

  • DIN: 02569035
  • Drug code: 107131
  • DPD status: Marketed
  • Therapeutic class: L01X OTHER ANTINEOPLASTIC AGENTS

ORZEYFUL

OVEPOREXTON 2MG; OVEPOREXTON .05MG; OVEPOREXTON 1MG

Sponsor: TAKEDA PHARMS USA

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220860
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Unclassified

ETCAMAH

CAMIZESTRANT 75 MG

Company: ASTRAZENECA CANADA INC

Authorization date:

Data pulled:

Therapeutic class L02BA05 CAMIZESTRANT did not match one condition rule, so the condition is Unclassified.

  • DIN: 02570572
  • Drug code: 107271
  • DPD status: Approved
  • Therapeutic class: L02BA05 CAMIZESTRANT

July 2026

Health Canada

Unclassified

AMBELVIST

GADOQUATRANE 257.9 MG

Company: BAYER INC

Authorization date:

Data pulled:

Therapeutic class V08CA13 GADOQUATRANE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02570424
  • Drug code: 107257
  • DPD status: Approved
  • Therapeutic class: V08CA13 GADOQUATRANE

SIMTRIYO

CENTANAFADINE HYDROCHLORIDE 280MG

Sponsor: OTSUKA PHARMACEUTICAL CO LTD

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA218145
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE, EXTENDED RELEASE

JIDEYTRO

ZIDESAMTINIB 25MG; ZIDESAMTINIB 100MG

Sponsor: NUVALENT

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220185
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Unclassified

VUEWAY

GADOPICLENOL 485.1 MG

Company: BRACCO IMAGING CANADA

Original market date:

Data pulled:

Therapeutic class V08CA12 GADOPICLENOL did not match one condition rule, so the condition is Unclassified.

  • DIN: 02567334
  • Drug code: 106975
  • DPD status: Marketed
  • Therapeutic class: V08CA12 GADOPICLENOL

Health Canada

Unclassified

MRESVIA

*RSV F-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA 50 MCG

Company: MODERNA BIOPHARMA CANADA CORPORATION

Original market date:

Data pulled:

Therapeutic class J07BX05 RESPIRATORY SYNCYTIAL VIRUS VACCINE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02552914
  • Drug code: 104187
  • DPD status: Marketed
  • Therapeutic class: J07BX05 RESPIRATORY SYNCYTIAL VIRUS VACCINE

LIPFENDRA

ENLICITIDE DECANOATE EQ 20MG BASE

Sponsor: MSD

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220848
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Unclassified

LYNKUET

ELINZANETANT 60 MG

Company: BAYER INC

Original market date:

Data pulled:

Therapeutic class G02CX07 ELINZANETANT did not match one condition rule, so the condition is Unclassified.

  • DIN: 02559714
  • Drug code: 106284
  • DPD status: Marketed
  • Therapeutic class: G02CX07 ELINZANETANT

REVTORPYK

GEDATOLISIB 180MG/VIAL

Sponsor: CELCUITY

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219908
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: POWDER
  • Route: INTRAVENOUS

Health Canada

Unclassified

SCENESSE

AFAMELANOTIDE (AFAMELANOTIDE ACETATE) 16 MG

Company: CLINUVEL, INC.

Authorization date:

Data pulled:

Therapeutic class D02BB02 AFAMELANOTIDE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02569825
  • Drug code: 107203
  • DPD status: Approved
  • Therapeutic class: D02BB02 AFAMELANOTIDE

Health Canada

Unclassified

JOENJA

LENIOLISIB (LENIOLISIB PHOSPHATE) 70 MG

Company: PHARMING TECHNOLOGIES B.V.

Authorization date:

Data pulled:

Therapeutic class L03AX22 LENIOLISIB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02569809
  • Drug code: 107201
  • DPD status: Approved
  • Therapeutic class: L03AX22 LENIOLISIB

TRUTAKNA

ATACICEPT-VYMJ 150MG/ML

Sponsor: VERA THERAPEUTICS INC.

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761486
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: SUBCUTANEOUS

Health Canada

Unclassified

KISUNLA

DONANEMAB 17.5 MG

Company: ELI LILLY CANADA INC

Original market date:

Data pulled:

Therapeutic class N06DX05 DONANEMAB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02567725
  • Drug code: 107011
  • DPD status: Marketed
  • Therapeutic class: N06DX05 DONANEMAB

Health Canada

Cardiovascular

REDEMPLO

PLOZASIRAN (PLOZASIRAN SODIUM) 25 MG

Company: ARROWHEAD PHARMACEUTICALS, INC.

Original market date:

Data pulled:

Condition mapped from Health Canada ATC C10AX OTHER LIPID MODIFYING AGENTS.

  • DIN: 02564327
  • Drug code: 106703
  • DPD status: Marketed
  • Therapeutic class: C10AX OTHER LIPID MODIFYING AGENTS

Health Canada

Cardiovascular

VANRAFIA

ATRASENTAN (ATRASENTAN HYDROCHLORIDE) 0.75 MG

Company: NOVARTIS PHARMACEUTICALS CANADA INC

Authorization date:

Data pulled:

Condition mapped from Health Canada ATC C09XX OTHER AGENTS ACTING ON THE RENIN -ANGIOTENSIN SYSTEM.

  • DIN: 02569590
  • Drug code: 107182
  • DPD status: Approved
  • Therapeutic class: C09XX OTHER AGENTS ACTING ON THE RENIN -ANGIOTENSIN SYSTEM

June 2026

LUMVOA

VELIGROTUG-VVZE 500MG/10ML

Sponsor: VIRIDIAN THERAPEUTICS INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761530
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTION

Health Canada

Unclassified

VIMKUNYA

CHIKUNGUNYA VIRUS VIRUS-LIKE PARTICLE 40 MCG

Company: BAVARIAN NORDIC AS

Authorization date:

Data pulled:

Therapeutic class J07BP02 CHIKUNGUNYA, VIRUS-LIKE PARTICLES did not match one condition rule, so the condition is Unclassified.

  • DIN: 02569078
  • Drug code: 107134
  • DPD status: Approved
  • Therapeutic class: J07BP02 CHIKUNGUNYA, VIRUS-LIKE PARTICLES

UTEBZI

TEBIPENEM PIVOXIL HYDROBROMIDE EQ 300MG BASE

Sponsor: GLAXOSMITHKLINE

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA215960
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

AMBELVIST

GADOQUATRANE 7.737GM/30ML (257.9MG/ML); GADOQUATRANE 2.579GM/10ML (257.9MG/ML); GADOQUATRANE 0.5158GM/2ML (257.9MG/ML); GADOQUATRANE 16.7635GM/65ML (257.9MG/ML); GADOQUATRANE 3.8685GM/15ML (257.9MG/ML); GADOQUATRANE 1.93425GM/7.5ML (257.9MG/ML)

Sponsor: BAYER HEALTHCARE

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219627
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: INTRAVENOUS
  • Submission property: Orphan

May 2026

CYPSEDO

CIPEPOFOL 50MG/20ML (2.5MG/ML)

Sponsor: HAISCO

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220482
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: EMULSION
  • Route: INTRAVENOUS

Health Canada

Unclassified

LOARGYS

PEGZILARGINASE 5 MG

Company: IMMEDICA PHARMA AB

Authorization date:

Data pulled:

Therapeutic class A16AB24 PEGZILARGINASE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02568713
  • Drug code: 107101
  • DPD status: Approved
  • Therapeutic class: A16AB24 PEGZILARGINASE

XOCOVA

ENSITRELVIR 125MG

Sponsor: SHIONOGI

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220442
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

DECNUPAZ

PIVEKIMAB SUNIRINE-PVZY 2MG

Sponsor: ABBVIE INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761460
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: VIAL
  • Route: SINGLE-DOSE
  • Submission property: Orphan

HEPCLUDEX

BULEVIRTIDE-GMOD 8.5MG

Sponsor: GILEAD SCIENCES INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761468
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTION
  • Route: POWDER,FOR SOLUTION
  • Submission property: Orphan

BAXFENDY

BAXDROSTAT 1MG; BAXDROSTAT 2MG

Sponsor: ASTRAZENECA AB

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219878
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

BEQALZI

SONROTOCLAX 20MG; SONROTOCLAX 1MG; SONROTOCLAX 80MG; SONROTOCLAX 5MG

Sponsor: BEONE MEDICINES USA

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220711
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Unclassified

HEMGENIX

ETRANACOGENE DEZAPARVOVEC 10000000000000 GENOME COPIES

Company: CSL BEHRING CANADA INC

Original market date:

Data pulled:

Therapeutic class B02BD16 ETRANACOGENE DEZAPARVOVEC did not match one condition rule, so the condition is Unclassified.

  • DIN: 02542560
  • Drug code: 103109
  • DPD status: Marketed
  • Therapeutic class: B02BD16 ETRANACOGENE DEZAPARVOVEC

Health Canada

Unclassified

ELFABRIO

PEGUNIGALSIDASE ALFA 5 MG; PEGUNIGALSIDASE ALFA 20 MG

Company: CHIESI FARMACEUTICI S.P.A.

Original market date:

Data pulled:

Therapeutic class A16AB20 PEGUNIGALSIDASE ALFA did not match one condition rule, so the condition is Unclassified.

  • DIN: 02563568, 02563576
  • Drug code: 106633, 106634
  • DPD status: Marketed
  • Therapeutic class: A16AB20 PEGUNIGALSIDASE ALFA

Health Canada

Oncology

LUNSUMIO

MOSUNETUZUMAB 1 MG

Company: HOFFMANN-LA ROCHE LIMITED

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01FX25 MOSUNETUZUMAB.

  • DIN: 02565226
  • Drug code: 106784
  • DPD status: Marketed
  • Therapeutic class: L01FX25 MOSUNETUZUMAB

Health Canada

Unclassified

VOXZOGO

VOSORITIDE 0.4 MG; VOSORITIDE 0.56 MG; VOSORITIDE 1.2 MG

Company: BIOMARIN INTERNATIONAL LIMITED

Original market date:

Data pulled:

Therapeutic class M05BX07 VOSORITIDE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02564653, 02564661, 02564688
  • Drug code: 106734, 106735, 106736
  • DPD status: Marketed
  • Therapeutic class: M05BX07 VOSORITIDE

VEPPANU

VEPDEGESTRANT 200MG; VEPDEGESTRANT 100MG

Sponsor: RIGEL PHARMS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219835
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

April 2026

Health Canada

Unclassified

AGAMREE

VAMOROLONE 40 MG

Company: KYE PHARMACEUTICALS INC.

Original market date:

Data pulled:

Therapeutic class H02AB18 VAMOROLONE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02561506
  • Drug code: 106446
  • DPD status: Marketed
  • Therapeutic class: H02AB18 VAMOROLONE

Health Canada

Oncology

HYRNUO

SEVABERTINIB 10 MG

Company: BAYER INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01EH06 SEVABERTINIB.

  • DIN: 02563444
  • Drug code: 106622
  • DPD status: Marketed
  • Therapeutic class: L01EH06 SEVABERTINIB

FOUNDAYO

ORFORGLIPRON CALCIUM EQ 2.5MG BASE; ORFORGLIPRON CALCIUM EQ 14.5MG BASE; ORFORGLIPRON CALCIUM EQ 5.5MG BASE; ORFORGLIPRON CALCIUM EQ 0.8MG BASE; ORFORGLIPRON CALCIUM EQ 17.2MG BASE; ORFORGLIPRON CALCIUM EQ 9MG BASE

Sponsor: ELI LILLY AND CO

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220934
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Oncology

TEVIMBRA

TISLELIZUMAB 100 MG

Company: BEONE MEDICINES I GMBH

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01FF09 TISLELIZUMAB.

  • DIN: 02564009
  • Drug code: 106674
  • DPD status: Marketed
  • Therapeutic class: L01FF09 TISLELIZUMAB

March 2026

AWIQLI FLEXTOUCH

INSULIN ICODEC

Sponsor: NOVO NORDISK INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761326
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTION
  • Route: SOLUTION
  • Submission property: Orphan

LIFYORLI (COPACKAGED)

RELACORILANT 100MG

Sponsor: CORCEPT THERAP

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220641
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL

AVLAYAH

TIVIDENOFUSP ALFA-EKNM 150MG/VIAL

Sponsor: DENALI THERAPEUTICS INC.

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761485
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTION
  • Route: POWDER,FOR SOLUTION
  • Submission property: Orphan

ICOTYDE

ICOTROKINRA HYDROCHLORIDE EQ 200MG BASE

Sponsor: JANSSEN BIOTECH

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220149
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

LYNAVOY

LINERIXIBAT 40MG

Sponsor: INTERCEPT

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220295
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Oncology

ADSTILADRIN

NADOFARAGENE FIRADENOVEC 300000000000 VP

Company: FERRING INC

Authorization date:

Data pulled:

Condition mapped from Health Canada ATC L01XL10 NADOFARAGENE FIRADENOVEC.

  • DIN: 02566680
  • Drug code: 106917
  • DPD status: Approved
  • Therapeutic class: L01XL10 NADOFARAGENE FIRADENOVEC

Health Canada

Unclassified

CYSKLAR

CYSTEAMINE HYDROCHLORIDE 0.44 % W/V

Company: LEADIANT BIOSCIENCES, INC

Authorization date:

Data pulled:

Therapeutic class S01XA21 MERCAPTAMINE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02566524
  • Drug code: 106902
  • DPD status: Approved
  • Therapeutic class: S01XA21 MERCAPTAMINE

February 2026

YUVIWEL

NAVEPEGRITIDE 2.8MG/VIAL; NAVEPEGRITIDE 5.5MG/VIAL; NAVEPEGRITIDE 1.3MG/VIAL

Sponsor: ASCENDIS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219164
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: POWDER
  • Route: SUBCUTANEOUS
  • Submission property: Orphan

Health Canada

Unclassified

NEMLUVIO

NEMOLIZUMAB 30 MG

Company: GALDERMA CANADA INC.

Original market date:

Data pulled:

Therapeutic class D11AH12 NEMOLIZUMAB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02563673
  • Drug code: 106644
  • DPD status: Marketed
  • Therapeutic class: D11AH12 NEMOLIZUMAB

LOARGYS

PEGZILARGINASE-NBLN 0.1MG/KG

Sponsor: IMMEDICA PHARMA AB

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761211
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: Injectable
  • Route: Injection
  • Submission property: Orphan

BYSANTI

MILSAPERIDONE 4MG; MILSAPERIDONE 1MG; MILSAPERIDONE 10MG; MILSAPERIDONE 6MG; MILSAPERIDONE 2MG; MILSAPERIDONE 12MG; MILSAPERIDONE 8MG

Sponsor: VANDA PHARMS INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220358
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

ADQUEY

DIFAMILAST 1%

Sponsor: ACROTECH BIOPHARMA

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219474
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: OINTMENT
  • Route: TOPICAL

Health Canada

Unclassified

RIFAPENTINE TABLETS

RIFAPENTINE 150 MG

Company: MACLEODS PHARMACEUTICALS LIMITED

Authorization date:

Data pulled:

Therapeutic class J04AB05 RIFAPENTINE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02565706
  • Drug code: 106828
  • DPD status: Approved
  • Therapeutic class: J04AB05 RIFAPENTINE

Health Canada

Cardiovascular

NILEMDO

BEMPEDOIC ACID 180 MG

Company: HLS THERAPEUTICS INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC C10AX15 BEMPEDOIC ACID.

  • DIN: 02562782
  • Drug code: 106563
  • DPD status: Marketed
  • Therapeutic class: C10AX15 BEMPEDOIC ACID

Health Canada

Cardiovascular

TRYNGOLZA

OLEZARSEN (OLEZARSEN SODIUM) 80 MG

Company: CELYSTRA PHARMA INC.

Original market date:

Data pulled:

Condition mapped from Health Canada ATC C10AX OTHER LIPID MODIFYING AGENTS.

  • DIN: 02563886
  • Drug code: 106662
  • DPD status: Marketed
  • Therapeutic class: C10AX OTHER LIPID MODIFYING AGENTS

Health Canada

Unclassified

BAXDELA

DELAFLOXACIN (DELAFLOXACIN MEGLUMINE) 450 MG; DELAFLOXACIN (DELAFLOXACIN MEGLUMINE) 300 MG

Company: XEDITON PHARMACEUTICALS INC

Original market date:

Data pulled:

Therapeutic class J01MA23 DELAFLOXACIN did not match one condition rule, so the condition is Unclassified.

  • DIN: 02554429, 02554437
  • Drug code: 104328, 104329
  • DPD status: Marketed
  • Therapeutic class: J01MA23 DELAFLOXACIN

January 2026

Health Canada

Unclassified

ENFLONSIA

CLESROVIMAB 105 MG

Company: MERCK CANADA INC

Authorization date:

Data pulled:

Therapeutic class J06BD10 CLESROVIMAB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02565145
  • Drug code: 106778
  • DPD status: Approved
  • Therapeutic class: J06BD10 CLESROVIMAB

Health Canada

Unclassified

YORVIPATH

PALOPEGTERIPARATIDE 168 MCG

Company: PENDOPHARM DIVISION OF PHARMASCIENCE INC

Authorization date:

Data pulled:

Therapeutic class H05AA05 PALOPEGTERIPARATIDE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02565153
  • Drug code: 106779
  • DPD status: Approved
  • Therapeutic class: H05AA05 PALOPEGTERIPARATIDE

Health Canada

Oncology

LOQTORZI

TORIPALIMAB 40 MG

Company: APOTEX INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01FF13 TORIPALIMAB.

  • DIN: 02562219
  • Drug code: 106511
  • DPD status: Marketed
  • Therapeutic class: L01FF13 TORIPALIMAB

Health Canada

Unclassified

TEPEZZA

TEPROTUMUMAB 500 MG

Company: AMGEN CANADA INC

Original market date:

Data pulled:

Therapeutic class L04AG13 TEPROTUMUMAB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02557061
  • Drug code: 106043
  • DPD status: Marketed
  • Therapeutic class: L04AG13 TEPROTUMUMAB

Health Canada

Oncology

ZIIHERA

ZANIDATAMAB 300 MG

Company: JAZZ PHARMACEUTICALS IRELAND LIMITED

Authorization date:

Data pulled:

Condition mapped from Health Canada ATC L01FD07 ZANIDATAMAB.

  • DIN: 02564610
  • Drug code: 106730
  • DPD status: Approved
  • Therapeutic class: L01FD07 ZANIDATAMAB

ZYCUBO

COPPER HISTIDINATE 2.9MG/VIAL

Sponsor: SENTYNL THERAPS INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA211241
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: POWDER
  • Route: SUBCUTANEOUS
  • Submission property: Orphan

Health Canada

Oncology

ELAHERE

MIRVETUXIMAB SORAVTANSINE 100 MG

Company: ABBVIE CORPORATION

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01FX26 MIRVETUXIMAB SORAVTANSINE.

  • DIN: 02560771
  • Drug code: 106381
  • DPD status: Marketed
  • Therapeutic class: L01FX26 MIRVETUXIMAB SORAVTANSINE

December 2025

NEREUS

TRADIPITANT 85MG

Sponsor: VANDA PHARMS INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220152
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL

Health Canada

Cardiovascular

JERAYGO

APROCITENTAN 25 MG

Company: IDORSIA PHARMACEUTICALS LTD

Authorization date:

Data pulled:

Condition mapped from Health Canada ATC C02KN01 APROCITENTAN.

  • DIN: 02563991
  • Drug code: 106673
  • DPD status: Approved
  • Therapeutic class: C02KN01 APROCITENTAN

YARTEMLEA

NARSOPLIMAB-WUUG

Sponsor: OMEROS CORP

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761152
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTION
  • Submission property: Orphan

MYQORZO

AFICAMTEN 20MG; AFICAMTEN 10MG; AFICAMTEN 15MG; AFICAMTEN 5MG

Sponsor: CYTOKINETICS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219083
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Unclassified

ISTURISA

OSILODROSTAT (OSILODROSTAT PHOSPHATE) 1 MG; OSILODROSTAT (OSILODROSTAT PHOSPHATE) 5 MG

Company: RECORDATI RARE DISEASES CANADA INC

Original market date:

Data pulled:

Therapeutic class H02CA02 OSILODROSTAT did not match one condition rule, so the condition is Unclassified.

  • DIN: 02558912, 02558920
  • Drug code: 106212, 106213
  • DPD status: Marketed
  • Therapeutic class: H02CA02 OSILODROSTAT

EXDENSUR

DEPEMOKIMAB-ULAA 100MG

Sponsor: GLAXOSMITHKLINE LLC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761458
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTION

Health Canada

Unclassified

LEQEMBI

LECANEMAB 100 MG

Company: EISAI LIMITED

Original market date:

Data pulled:

Therapeutic class N06DX04 LECANEMAB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02562383
  • Drug code: 106527
  • DPD status: Marketed
  • Therapeutic class: N06DX04 LECANEMAB

CARDAMYST

ETRIPAMIL 70MG

Sponsor: MILESTONE PHARMS USA

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA218571
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SPRAY
  • Route: NASAL

LEROCHOL

LERODALCIBEP-LIGA 300MG/1.2ML

Sponsor: LIB THERAPEUTICS, INC.

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761427
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: INJECTION

NUZOLVENCE

ZOLIFLODACIN 3GM/PACKET

Sponsor: ENTASIS THERAP

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219491
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: FOR SUSPENSION
  • Route: ORAL

Health Canada

Unclassified

POMBILITI

CIPAGLUCOSIDASE ALFA 105 MG

Company: AMICUS THERAPEUTICS CANADA INC.

Original market date:

Data pulled:

Therapeutic class A16AB23 CIPAGLUCOSIDASE ALFA did not match one condition rule, so the condition is Unclassified.

  • DIN: 02556898
  • Drug code: 106027
  • DPD status: Marketed
  • Therapeutic class: A16AB23 CIPAGLUCOSIDASE ALFA

Health Canada

Unclassified

ZURZUVAE

ZURANOLONE 30 MG

Company: BIOGEN CANADA INC

Authorization date:

Data pulled:

Therapeutic class N06AX31 ZURANOLONE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02563541
  • Drug code: 106632
  • DPD status: Approved
  • Therapeutic class: N06AX31 ZURANOLONE

Health Canada

Unclassified

SEPHIENCE

SEPIAPTERIN 250 MG; SEPIAPTERIN 1000 MG

Company: PTC THERAPEUTICS INTERNATIONAL LIMITED

Original market date:

Data pulled:

Therapeutic class A16AX28 SEPIAPTERIN did not match one condition rule, so the condition is Unclassified.

  • DIN: 02561824, 02561832
  • Drug code: 106475, 106476
  • DPD status: Marketed
  • Therapeutic class: A16AX28 SEPIAPTERIN

November 2025

Health Canada

Unclassified

LYVDELZI

SELADELPAR (SELADELPAR LYSINE) 10 MG

Company: GILEAD SCIENCES CANADA INC

Original market date:

Data pulled:

Therapeutic class A05AX07 SELADELPAR did not match one condition rule, so the condition is Unclassified.

  • DIN: 02561492
  • Drug code: 106445
  • DPD status: Marketed
  • Therapeutic class: A05AX07 SELADELPAR

VOYXACT

SIBEPRENLIMAB-SZSI 400MG/2ML(200MG/ML)

Sponsor: OTSUKA PHARM CO LTD

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761434
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: INJECTION

HYRNUO

SEVABERTINIB 10MG

Sponsor: BAYER HEALTHCARE

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219972
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

REDEMPLO

PLOZASIRAN SODIUM EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

Sponsor: ARROWHEAD

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219947
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: SUBCUTANEOUS
  • Submission property: Orphan

KOMZIFTI

ZIFTOMENIB 200MG

Sponsor: KURA

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA220305
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Unclassified

PIASKY

CROVALIMAB 170 MG

Company: HOFFMANN-LA ROCHE LIMITED

Original market date:

Data pulled:

Therapeutic class L04AJ07 CROVALIMAB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02558262
  • Drug code: 104492
  • DPD status: Marketed
  • Therapeutic class: L04AJ07 CROVALIMAB

KYGEVVI

DOXECITINE 2GM/PACKET; DOXRIBTIMINE 2GM/PACKET

Sponsor: UCB INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219792
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: FOR SOLUTION
  • Route: ORAL
  • Submission property: Orphan

October 2025

Health Canada

Oncology

VANFLYTA

QUIZARTINIB (QUIZARTINIB HYDROCHLORIDE) 17.7 MG

Company: DAIICHI SANKYO PHARMA CANADA LIMITED

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01EX11 QUIZARTINIB.

  • DIN: 02558351
  • Drug code: 106161
  • DPD status: Marketed
  • Therapeutic class: L01EX11 QUIZARTINIB

LYNKUET

ELINZANETANT 60MG

Sponsor: BAYER HLTHCARE

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219469
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL

Health Canada

Viral infections

HEPCLUDEX

BULEVIRTIDE (BULEVIRTIDE ACETATE) 2 MG

Company: GILEAD SCIENCES CANADA INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC J05AX28 BULEVIRTIDE.

  • DIN: 02560178
  • Drug code: 106325
  • DPD status: Marketed
  • Therapeutic class: J05AX28 BULEVIRTIDE

JASCAYD

NERANDOMILAST 18MG; NERANDOMILAST 9MG

Sponsor: BOEHRINGER INGELHEIM

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA218764
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

September 2025

RHAPSIDO

REMIBRUTINIB 25MG

Sponsor: NOVARTIS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA218436
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Unclassified

MNEXSPIKE

*SARSCOV2 S-PROTEIN NTD-RBD SUBDOMAINS MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA 10 MCG

Company: MODERNA BIOPHARMA CANADA CORPORATION

Authorization date:

Data pulled:

Therapeutic class J07BN01 COVID-19, RNA-BASED VACCINE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02561433
  • Drug code: 106440
  • DPD status: Approved
  • Therapeutic class: J07BN01 COVID-19, RNA-BASED VACCINE

INLURIYO

IMLUNESTRANT TOSYLATE EQ 200MG BASE

Sponsor: ELI LILLY AND CO

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA218881
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Unclassified

NDUVRA

TAPINAROF 1 %

Company: ORGANON CANADA INC.

Original market date:

Data pulled:

Therapeutic class D05AX07 TAPINAROF did not match one condition rule, so the condition is Unclassified.

  • DIN: 02448254
  • Drug code: 93392
  • DPD status: Marketed
  • Therapeutic class: D05AX07 TAPINAROF

PALSONIFY

PALTUSOTINE HYDROCHLORIDE EQ 20MG BASE; PALTUSOTINE HYDROCHLORIDE EQ 30MG BASE

Sponsor: CRINETICS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219070
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

FORZINITY

ELAMIPRETIDE HYDROCHLORIDE EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)

Sponsor: STEALTH BIOTHERAPS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA215244
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: SUBCUTANEOUS
  • Submission property: Orphan

KEYTRUDA QLEX

PEMBROLIZUMAB 790MG/9600UNITS(4.8ML); BERAHYALURONIDASE ALFA-PMPH; PEMBROLIZUMAB 395MG/4800UNITS(2.4ML)

Sponsor: MERCK SHARP DOHME

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761467
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: INJECTION

Health Canada

Unclassified

ORITINIV

ORITAVANCIN (ORITAVANCIN PHOSPHATE) 400 MG; ORITAVANCIN (ORITAVANCIN PHOSPHATE) 1200 MG

Company: XEDITON PHARMACEUTICALS INC

Authorization date:

Data pulled:

Therapeutic class J01XA05 ORITAVANCIN did not match one condition rule, so the condition is Unclassified.

  • DIN: 02561042, 02561050
  • Drug code: 106404, 106405
  • DPD status: Approved
  • Therapeutic class: J01XA05 ORITAVANCIN

Health Canada

Unclassified

RYSTIGGO

ROZANOLIXIZUMAB 280 MG

Company: UCB CANADA INC

Original market date:

Data pulled:

Therapeutic class L04AL02 ROZANOLIXIZUMAB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02556081
  • Drug code: 104480
  • DPD status: Marketed
  • Therapeutic class: L04AL02 ROZANOLIXIZUMAB

August 2025

WAYRILZ

RILZABRUTINIB 400MG

Sponsor: GENZYME CORP

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219685
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Unclassified

ANZUPGO

DELGOCITINIB 20 MG

Company: LEO PHARMA INC

Original market date:

Data pulled:

Therapeutic class D11AH11 DELGOCITINIB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02560704
  • Drug code: 106374
  • DPD status: Marketed
  • Therapeutic class: D11AH11 DELGOCITINIB

DAWNZERA (AUTOINJECTOR)

DONIDALORSEN SODIUM EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)

Sponsor: IONIS PHARMS INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219407
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: SUBCUTANEOUS
  • Submission property: Orphan

Health Canada

Diabetes

TZIELD

TEPLIZUMAB 2 MG

Company: SANOFI-AVENTIS CANADA INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC A10XX01 TEPLIZUMAB.

  • DIN: 02557347
  • Drug code: 106068
  • DPD status: Marketed
  • Therapeutic class: A10XX01 TEPLIZUMAB

Health Canada

Oncology

AMTAGVI

LIFILEUCEL 72000000000 CELLS

Company: IOVANCE BIOTHERAPEUTICS, INC.

Authorization date:

Data pulled:

Condition mapped from Health Canada ATC L01XL11 LIFILEUCEL.

  • DIN: 02560232
  • Drug code: 106331
  • DPD status: Approved
  • Therapeutic class: L01XL11 LIFILEUCEL

Health Canada

Oncology

ZYNYZ

RETIFANLIMAB 25 MG

Company: INCYTE CORPORATION

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01FF10 RETIFANLIMAB.

  • DIN: 02555239
  • Drug code: 104399
  • DPD status: Marketed
  • Therapeutic class: L01FF10 RETIFANLIMAB

BRINSUPRI

BRENSOCATIB 25MG; BRENSOCATIB 10MG

Sponsor: INSMED INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA217673
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Oncology

BLENREP

BELANTAMAB MAFODOTIN 70 MG; BELANTAMAB MAFODOTIN 100 MG

Company: GLAXOSMITHKLINE INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01FX15 BELANTAMAB MAFODOTIN.

  • DIN: 02559617, 02559625
  • Drug code: 106275, 106276
  • DPD status: Marketed
  • Therapeutic class: L01FX15 BELANTAMAB MAFODOTIN

HERNEXEOS

ZONGERTINIB 60MG

Sponsor: BOEHRINGER INGELHEIM

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219042
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Unclassified

ANDEMBRY

GARADACIMAB 200 MG

Company: CSL BEHRING CANADA INC

Authorization date:

Data pulled:

Therapeutic class B06AC07 GARADACIMAB did not match one condition rule, so the condition is Unclassified.

  • DIN: 02559765
  • Drug code: 106289
  • DPD status: Approved
  • Therapeutic class: B06AC07 GARADACIMAB

MODEYSO

DORDAVIPRONE HYDROCHLORIDE EQ 125MG BASE

Sponsor: CHIMERIX

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219876
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL
  • Submission property: Orphan

July 2025

VIZZ

ACECLIDINE HYDROCHLORIDE EQ 1.44% BASE

Sponsor: LENZ THERAP

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA218585
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION/DROPS
  • Route: OPHTHALMIC

Health Canada

Unclassified

DYANAVEL XR

AMPHETAMINE (AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE (COMPLEXED WITH SODIUM POLYSTYRENE SULFONATE)) 2.5 MG

Company: KYE PHARMACEUTICALS INC.

Authorization date:

Data pulled:

Therapeutic class N06BA01 AMFETAMINE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02559781
  • Drug code: 106291
  • DPD status: Approved
  • Therapeutic class: N06BA01 AMFETAMINE

SEPHIENCE

SEPIAPTERIN 1GM/PACKET; SEPIAPTERIN 250MG/PACKET

Sponsor: PTC THERAP

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219666
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: POWDER
  • Route: ORAL
  • Submission property: Orphan

ANZUPGO

DELGOCITINIB 2%

Sponsor: LEO PHARMA AS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219155
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CREAM
  • Route: TOPICAL

EKTERLY

SEBETRALSTAT 300MG

Sponsor: KALVISTA

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219301
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL
  • Submission property: Orphan

LYNOZYFIC

LINVOSELTAMAB-GCPT 5MG/2ML

Sponsor: RENGENERON PHARMACEUTICALS, INC.

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761400
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: INJECTION
  • Submission property: Orphan

ZEGFROVY

SUNVOZERTINIB 200MG; SUNVOZERTINIB 150MG

Sponsor: DIZAL

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219839
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

June 2025

DATROWAY

DATOPOTAMAB DERUXTECAN-DLNK 100MG

Sponsor: DAIICHI SANKYO INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761464
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: INJECTION

ANDEMBRY

GARADACIMAB-GXII 200MG/1.2ML

Sponsor: CSL BEHRING LLC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761367
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: SUBCUTANEOUS
  • Submission property: Orphan

IBTROZI

TALETRECTINIB ADIPATE EQ 200MG BASE

Sponsor: NUVATION

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219713
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL
  • Submission property: Orphan

Health Canada

Unclassified

REBYOTA

FECAL MICROBIOTA 50000000000 CFU

Company: FERRING INC

Original market date:

Data pulled:

Therapeutic class A07FA ANTIDIARRHEAL MICROORGANISMS did not match one condition rule, so the condition is Unclassified.

  • DIN: 02555948
  • Drug code: 104466
  • DPD status: Marketed
  • Therapeutic class: A07FA ANTIDIARRHEAL MICROORGANISMS

ENFLONSIA

CLESROVIMAB-CFOR 105MG/0.7ML

Sponsor: MERCK SHARP DOHME

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761432
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTION
  • Route: SOLUTION

May 2025

Health Canada

Unclassified

SKYCLARYS

OMAVELOXOLONE 50 MG

Company: BIOGEN CANADA INC

Original market date:

Data pulled:

Therapeutic class N07XX OTHER NERVOUS SYSTEM DRUGS did not match one condition rule, so the condition is Unclassified.

  • DIN: 02556219
  • Drug code: 104491
  • DPD status: Marketed
  • Therapeutic class: N07XX OTHER NERVOUS SYSTEM DRUGS

TRYPTYR

ACOLTREMON 0.003%

Sponsor: ALCON LABS INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA217370
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION/DROPS
  • Route: OPHTHALMIC

Health Canada

Unclassified

IQIRVO

ELAFIBRANOR 80 MG

Company: IPSEN BIOPHARMACEUTICALS CANADA INC

Original market date:

Data pulled:

Therapeutic class A05AX06 ELAFIBRANOR did not match one condition rule, so the condition is Unclassified.

  • DIN: 02557010
  • Drug code: 106038
  • DPD status: Marketed
  • Therapeutic class: A05AX06 ELAFIBRANOR

EMRELIS

TELISOTUZUMAB VEDOTIN-TLLV 20MG; TELISOTUZUMAB VEDOTIN-TLLV 100MG

Sponsor: ABBVIE INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761384
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: VIAL
  • Route: SINGLE-DOSE

Health Canada

Unclassified

QALSODY

TOFERSEN 100 MG

Company: BIOGEN CANADA INC

Original market date:

Data pulled:

Therapeutic class N07XX22 TOFERSEN did not match one condition rule, so the condition is Unclassified.

  • DIN: 02555735
  • Drug code: 104447
  • DPD status: Marketed
  • Therapeutic class: N07XX22 TOFERSEN

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)

AVUTOMETINIB POTASSIUM EQ 0.8MG BASE; DEFACTINIB HYDROCHLORIDE EQ 200MG BASE

Sponsor: VERASTEM INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219616
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE, TABLET
  • Route: ORAL
  • Submission property: Orphan

April 2025

IMAAVY

NIPOCALIMAB-AAHU 1200MG/6.5ML(185MG/ML); NIPOCALIMAB-AAHU 300MG/1.62ML(185MG/ML)

Sponsor: JANSSEN BIOTECH

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761430
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: INJECTION
  • Submission property: Orphan

Health Canada

Oncology

LAZCLUZE

LAZERTINIB (LAZERTINIB MESYLATE) 80 MG; LAZERTINIB (LAZERTINIB MESYLATE) 240 MG

Company: JANSSEN INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01EB09 LAZERTINIB.

  • DIN: 02555964, 02555972
  • Drug code: 104468, 104469
  • DPD status: Marketed
  • Therapeutic class: L01EB09 LAZERTINIB

PENPULIMAB-KCQX

PENPULIMAB-KCQX 100MG/10ML(10MG/ML)

Sponsor: AKESO BIOPHARMA

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761258
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: INTRAVENOUS
  • Submission property: Orphan

VANRAFIA

ATRASENTAN HYDROCHLORIDE EQ 0.75MG BASE

Sponsor: NOVARTIS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219208
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Oncology

VYLOY

ZOLBETUXIMAB 100 MG

Company: ASTELLAS PHARMA CANADA INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01FX31 ZOLBETUXIMAB.

  • DIN: 02553996
  • Drug code: 104288
  • DPD status: Marketed
  • Therapeutic class: L01FX31 ZOLBETUXIMAB

March 2025

Health Canada

Unclassified

FABHALTA

IPTACOPAN (IPTACOPAN HYDROCHLORIDE) 200 MG

Company: NOVARTIS PHARMACEUTICALS CANADA INC

Original market date:

Data pulled:

Therapeutic class L04AJ08 IPTACOPAN did not match one condition rule, so the condition is Unclassified.

  • DIN: 02554313
  • Drug code: 104318
  • DPD status: Marketed
  • Therapeutic class: L04AJ08 IPTACOPAN

QFITLIA

FITUSIRAN SODIUM EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML); FITUSIRAN SODIUM EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML)

Sponsor: GENZYME CORP

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219019
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: SOLUTION
  • Route: SUBCUTANEOUS
  • Submission property: Orphan

Health Canada

Unclassified

ALTUVIIIO

*ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN 250 UNIT

Company: SANOFI-AVENTIS CANADA INC

Authorization date:

Data pulled:

Therapeutic class B02BD02 COAGULATION FACTOR VIII did not match one condition rule, so the condition is Unclassified.

  • DIN: 02448114
  • Drug code: 93380
  • DPD status: Approved
  • Therapeutic class: B02BD02 COAGULATION FACTOR VIII

BLUJEPA

GEPOTIDACIN MESYLATE EQ 750MG BASE

Sponsor: GLAXOSMITHKLINE

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA218230
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

Health Canada

Unclassified

KAVIGALE

SIPAVIBART 150 MG

Company: ASTRAZENECA CANADA INC

Authorization date:

Data pulled:

Therapeutic class J06BD09 SIPAVIBART did not match one condition rule, so the condition is Unclassified.

  • DIN: 02556332
  • Drug code: 104503
  • DPD status: Approved
  • Therapeutic class: J06BD09 SIPAVIBART

Health Canada

Unclassified

ZILBRYSQ

ZILUCOPLAN (ZILUCOPLAN SODIUM) 16.6 MG; ZILUCOPLAN (ZILUCOPLAN SODIUM) 23 MG; ZILUCOPLAN (ZILUCOPLAN SODIUM) 32.4 MG

Company: UCB CANADA INC

Original market date:

Data pulled:

Therapeutic class L04AJ06 ZILUCOPLAN did not match one condition rule, so the condition is Unclassified.

  • DIN: 02549220, 02549239, 02549247
  • Drug code: 103809, 103810, 103811
  • DPD status: Marketed
  • Therapeutic class: L04AJ06 ZILUCOPLAN

Health Canada

Unclassified

VEOZAH

FEZOLINETANT 45 MG

Company: ASTELLAS PHARMA CANADA INC

Original market date:

Data pulled:

Therapeutic class G02CX06 FEZOLINETANT did not match one condition rule, so the condition is Unclassified.

  • DIN: 02553600
  • Drug code: 104252
  • DPD status: Marketed
  • Therapeutic class: G02CX06 FEZOLINETANT

Health Canada

Oncology

ZYNLONTA

LONCASTUXIMAB TESIRINE 10 MG

Company: SWEDISH ORPHAN BIOVITRUM AB (PUBL)

Authorization date:

Data pulled:

Condition mapped from Health Canada ATC L01FX22 LONCASTUXIMAB TESIRINE.

  • DIN: 02556138
  • Drug code: 104483
  • DPD status: Approved
  • Therapeutic class: L01FX22 LONCASTUXIMAB TESIRINE

Health Canada

Viral infections

XOFLUZA

BALOXAVIR MARBOXIL 80 MG

Company: HOFFMANN-LA ROCHE LIMITED

Original market date:

Data pulled:

Condition mapped from Health Canada ATC J05AX25 BALOXAVIR MARBOXIL.

  • DIN: 02524163
  • Drug code: 101320
  • DPD status: Marketed
  • Therapeutic class: J05AX25 BALOXAVIR MARBOXIL

February 2025

ROMVIMZA

VIMSELTINIB 20MG; VIMSELTINIB 30MG; VIMSELTINIB 14MG

Sponsor: DECIPHERA PHARMS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219304
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: CAPSULE
  • Route: ORAL

Health Canada

Unclassified

DAYBUE

TROFINETIDE 200 MG

Company: ACADIA PHARMACEUTICALS INC.

Original market date:

Data pulled:

Therapeutic class N07XX24 TROFINETIDE did not match one condition rule, so the condition is Unclassified.

  • DIN: 02552523
  • Drug code: 104149
  • DPD status: Marketed
  • Therapeutic class: N07XX24 TROFINETIDE

GOMEKLI

MIRDAMETINIB 3MG; MIRDAMETINIB 4MG; MIRDAMETINIB 1MG

Sponsor: SPRINGWORKS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219379
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET, FOR SUSPENSION
  • Route: ORAL
  • Submission property: Orphan

January 2025

JOURNAVX

SUZETRIGINE 50MG

Sponsor: VERTEX PHARMS INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA219209
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: TABLET
  • Route: ORAL

GRAFAPEX

TREOSULFAN 1GM/VIAL; TREOSULFAN 5GM/VIAL

Sponsor: MEDEXUS

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: NDA214759
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: POWDER
  • Route: INTRAVENOUS
  • Submission property: Orphan

Health Canada

Oncology

OJJAARA

MOMELOTINIB (MOMELOTINIB DIHYDROCHLORIDE) 100 MG; MOMELOTINIB (MOMELOTINIB DIHYDROCHLORIDE) 150 MG; MOMELOTINIB (MOMELOTINIB DIHYDROCHLORIDE) 200 MG

Company: GLAXOSMITHKLINE INC

Original market date:

Data pulled:

Condition mapped from Health Canada ATC L01EJ04 MOMELOTINIB.

  • DIN: 02552965, 02552973, 02552981
  • Drug code: 104193, 104194, 104195
  • DPD status: Marketed
  • Therapeutic class: L01EJ04 MOMELOTINIB

DATROWAY

DATOPOTAMAB DERUXTECAN-DLNK 100MG

Sponsor: DAIICHI SANKYO INC

Approval date:

Data pulled:

Drugs@FDA did not include an indication on this record, so the condition is Unclassified.

  • Application: BLA761394
  • Submission class: Type 1 - New Molecular Entity
  • Marketing status: Prescription
  • Dosage form: INJECTABLE
  • Route: IV (INFUSION)