← FDA DRUG APPROVALS

FDA NDA · NDA215244

FORZINITY

elamipretide hydrochloride

Sponsor: STEALTH BIOTHERAPS

APPLICATION
NDA215244
TYPE
NDA
ORIGINAL APPROVAL
2025-09-19
LATEST ACTION
2025-09-19
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FORZINITY · ReferencePrescription
ELAMIPRETIDE HYDROCHLORIDE EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-09-19Type 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 →