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FDA and Health Canada

New drug approvals, grouped by condition.

NewRx Radar lists original FDA new molecular entity approvals and Health Canada human drug products that are the first dated DPD record for their active ingredient, from January 1, 2025. Each row links to the government record. If a condition cannot be mapped, it stays Unclassified.

89FDA type 1 originals
115Health Canada first records
143Unclassified
10-16Data pulled October 16, 2026

Latest in this pull

All approvals

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

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