For right-sided infective endocarditis. ANDA 211961, held by Accord Hlthcare. Daptomycin.
As of Nov 13, 2026, ANDA 211961 (Daptomycin), held by Accord Hlthcare, was first approved by FDA on Jun 24, 2019, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 24, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin500MG/VIAL · powder;intravenous | Daptomycin | Rx |
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
