Elamipretide U.S. label context · version 1
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What does the U.S. product label say?
FORZINITY, revised September 2025 · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The label covers improved muscle strength in adults and children with Barth syndrome weighing at least 30 kg. Accelerated approval rests on an intermediate clinical endpoint and requires confirmation of clinical benefit. Label: 1 ↗
Which safety limits matter?
The label contraindicates serious hypersensitivity and warns about hypersensitivity reactions and benzyl-alcohol toxicity in neonates. Injection-site reactions were the most common adverse reactions. Label: 4, 5, 6 ↗
Label edition and source pins
FDA-hosted U.S. prescribing information. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
FORZINITY, revised September 2025: U.S. prescribing information
Label PDF SHA-256: 1a32a3b7452b7c33c4a60b7f9175f80fcce499775feb39b4c14743293e6bf618.