For right-sided infective endocarditis. ANDA 213623, held by Meitheal. Daptomycin.
As of Nov 13, 2026, ANDA 213623 (Daptomycin), held by Meitheal, was first approved by FDA on Jun 29, 2021, with 3 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 29, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin500MG/VIAL · powder;intravenous | Daptomycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2026 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 13, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 13, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 29, 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
