← FDA DRUG APPROVALS

FDA NDA · NDA215973

SUNLENCA

lenacapavir sodium

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA215973
TYPE
NDA
ORIGINAL APPROVAL
2022-12-22
LATEST ACTION
2026-03-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SUNLENCA · ReferencePrescription
LENACAPAVIR SODIUM EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-03-12Labeling · Supplement 19 · standard — Letter ↗AP
2024-11-25Efficacy · Supplement 6 · standard — Label ↗AP
2024-11-13Manufacturing (CMC) · Supplement 9AP
2024-07-17Labeling · Supplement 5 · 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.

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 →