Daptomycin

For right-sided infective endocarditis. ANDA 212513, held by Be Pharms. Daptomycin.

As of Nov 13, 2026, ANDA 212513 (Daptomycin), held by Be Pharms, was first approved by FDA on Jun 26, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 26, 2019
Review: Standard
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Jun 26, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Daptomycin500MG/VIAL · powder;intravenous	Daptomycin	Rx

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 13, 2022	Supplement 7Labeling · Standard review	Approved	None posted
Nov 13, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Nov 13, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Jun 26, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 212513
Drugs@FDA: Overview at FDA
Company: BE Pharmaceuticals

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