Daptomycin

For right-sided infective endocarditis. NDA 209949, held by Hikma. Daptomycin.

As of Nov 13, 2026, NDA 209949 (Daptomycin), held by Hikma, was first approved by FDA on Oct 20, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2017
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


May 5, 2021	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 5, 2021	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 20, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Daptomycin350MG/VIAL · powder;intravenous	Daptomycin	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Apr 30, 2025	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 6, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label
May 5, 2021	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 5, 2021	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 18, 2019	Supplement 3Labeling · Standard review	Approved	Label Letter
Oct 20, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 209949
Drugs@FDA: Overview at FDA
Company: Hikma

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