← FDA DRUG APPROVALS

FDA NDA · NDA215559

SOHONOS

palovarotene

Sponsor: IPSEN

APPLICATION
NDA215559
TYPE
NDA
ORIGINAL APPROVAL
2023-08-16
LATEST ACTION
2025-03-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SOHONOS · ReferencePrescription
PALOVAROTENE 10MG · CAPSULE · ORAL
SOHONOS · ReferencePrescription
PALOVAROTENE 2.5MG · CAPSULE · ORAL
SOHONOS · ReferencePrescription
PALOVAROTENE 1MG · CAPSULE · ORAL
SOHONOS · ReferencePrescription
PALOVAROTENE 5MG · CAPSULE · ORAL
SOHONOS · ReferencePrescription
PALOVAROTENE 1.5MG · CAPSULE · ORAL

Approval history

2025-03-13Efficacy · Supplement 2 · standard — Label ↗AP
2023-08-16Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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