← FDA DRUG APPROVALS

FDA NDA · NDA211970

VYONDYS 53

golodirsen

Sponsor: SAREPTA THERAPS INC

APPLICATION
NDA211970
TYPE
NDA
ORIGINAL APPROVAL
2019-12-12
LATEST ACTION
2024-06-04
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VYONDYS 53 · ReferencePrescription
GOLODIRSEN 100MG/2ML (50MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-06-04Labeling · Supplement 11 · standard — Letter ↗AP
2024-06-04Labeling · Supplement 10 · standard — Letter ↗AP
2021-02-11Labeling · Supplement 2 · standard — Letter ↗AP
2019-12-12Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →