For right-sided infective endocarditis. NDA 208385, held by Sagent Pharms Inc. Daptomycin.
As of Nov 14, 2026, NDA 208385 (Daptomycin), held by Sagent Pharms Inc, was first approved by FDA on Sep 12, 2017, with 5 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 |
|---|---|---|---|
| Sep 12, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin350MG/VIAL · powder;intravenous | Daptomycin | RxReference drug |
| Apr 30, 2025 | Supplement 11Labeling · Standard review | Approved | |
| Feb 7, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Feb 7, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Apr 3, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Aug 30, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Sep 12, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
