For right-sided infective endocarditis. ANDA 206005, held by Xellia Pharms Aps. Daptomycin.
As of Nov 13, 2026, ANDA 206005 (Daptomycin), held by Xellia Pharms Aps, was first approved by FDA on Jun 15, 2016, with 6 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 15, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin500MG/VIAL · powder;intravenous | Daptomycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 2020 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 9, 2020 | Supplement 19Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 14Labeling · Standard review | Approved | None posted |
| Dec 21, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 15, 2016 | 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
