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As of Nov 13, 2026, NDA 217630 (Daptomycin), held by Maia Pharms Inc, was first approved by FDA on Nov 21, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Nov 21, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of:
Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) and,
Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis,
Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). Limitations of Use:
Daptomycin for Injection is not indicated for the treatment of pneumonia.
Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
