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These highlights do not include all the information needed to use FORZINITY™ safely and effectively. See full prescribing information for FORZINITY. FORZINITY (elamipretide) injection, for subcutaneous use Initial U.S. Approval: 2025
Medication labelWhy this: Advisory · dailymed-prescription
FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- generic_name
- elamipretide hydrochloride
- product_names
- Elamipretide Hydrochloride
- ndc
- 72507-800, 72507-800-30, 72507-800-04
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en