Daptomycin

For right-sided infective endocarditis. NDA 210282, held by Hospira. Daptomycin.

As of Nov 13, 2026, NDA 210282 (Daptomycin), held by Hospira, was first approved by FDA on Jun 21, 2021, with 2 approved supplements and 1 published complete response letter.

First approved: Jun 21, 2021
Review: Standard
Supplements approved: 2
Complete response letters: 1

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 patients and,
Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, Limitations of Use:
This Daptomycin for Injection product is not approved for use in pediatric patients.
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 3 submissions below

Date	Submission	Status	Documents
Jun 21, 2021	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Mar 19, 2018	DaptomycinFacility Inspections, Product Quality	Approved

Products

2 strengths and forms

Product	Active ingredient	Marketing
Daptomycin350MG/VIAL · powder;intravenous	Daptomycin	RxReference drug
Daptomycin500MG/VIAL · powder;intravenous	Daptomycin	RxReference drug

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 30, 2025	Supplement 4Labeling · Standard review	Approved	Letter Label
Aug 8, 2022	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 21, 2021	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 210282
Drugs@FDA: Overview at FDA
Company: Hospira

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