For right-sided infective endocarditis. ANDA 215316, held by Qilu Pharm Hainan. Daptomycin.
As of Nov 13, 2026, ANDA 215316 (Daptomycin), held by Qilu Pharm Hainan, was first approved by FDA on Aug 24, 2021, with 2 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 |
|---|---|---|---|
| Aug 24, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin500MG/VIAL · powder;intravenous | Daptomycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 13, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 24, 2021 | 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
