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For right-sided infective endocarditis. ANDA 213425, held by Be Pharms. Daptomycin.
As of Nov 13, 2026, ANDA 213425 (Daptomycin), held by Be Pharms, was first approved by FDA on Aug 20, 2020, with 1 approved supplement and 0 published complete response letters.
First approved: Aug 20, 2020
Review: Standard
Supplements approved: 1
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 weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
