← FDA DRUG APPROVALS

FDA NDA · NDA215974

SUNLENCA

lenacapavir sodium

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA215974
TYPE
NDA
ORIGINAL APPROVAL
2022-12-22
LATEST ACTION
2026-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SUNLENCA · ReferencePrescription
LENACAPAVIR SODIUM EQ 300MG BASE · TABLET · ORAL

Approval history

2026-03-12Labeling · Supplement 14 · standard — Letter ↗AP
2024-11-25Efficacy · Supplement 8 · standard — Label ↗AP
2024-11-13Labeling · Supplement 9 · standard — Label ↗AP
2024-07-17Labeling · Supplement 7 · standard — Letter ↗AP
2022-12-22Type 1 - New Molecular Entity · Original · priority — Label ↗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.

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