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Review Type: 351(k) BLA, Standard Review Submission Date: January 28, 2024 Elamipretide (New Molecular Entity) Developer: Stealth BioTherapeutics Modality: Peptide PDUFA Date: January 29, 2025 Indication/Description: Cardiovascular congenital diseases / Mitochondrial protective peptide bound to cardiolipin, for treating Barth syndrome Review Type: Priority Review (Initially Standard Review, changed to Priority Review at the request of Stealth Bio) Submission Date: January 2024 Review Status: Initial submission in August 2021, FDA issued a Refuse to File (RTF) letter in October 2021

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