For right-sided infective endocarditis. ANDA 212667, held by Accord Hlthcare. Daptomycin.
As of Nov 13, 2026, ANDA 212667 (Daptomycin), held by Accord Hlthcare, was first approved by FDA on Jul 12, 2019, with 1 approved supplement 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 |
|---|---|---|---|
| Jul 12, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin350MG/VIAL · powder;intravenous | Daptomycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2026 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jul 12, 2019 | Original application | Approved |
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
