For right-sided infective endocarditis. ANDA 207104, held by Sagent Pharms Inc. Daptomycin.
As of Nov 13, 2026, ANDA 207104 (Daptomycin), held by Sagent Pharms Inc, was first approved by FDA on Nov 15, 2019, with 4 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 |
|---|---|---|---|
| Nov 15, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin500MG/VIAL · powder;intravenous | Daptomycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 19, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 15, 2019 | Original application | Approved | None posted |
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
