Cubicin, Cubicin Rf

NDA 21572, held by Cubist Pharms LLC. Daptomycin.

As of Nov 15, 2026, NDA 21572 (Cubicin, Cubicin Rf), held by Cubist Pharms LLC, was first approved by FDA on Sep 12, 2003, with 47 approved supplements and 0 published complete response letters.

First approved: Sep 12, 2003
Review: Priority
Supplements approved: 47
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 48 submissions below


Sep 1, 2017	Supplement 57Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Clinical Pharmacology Review Pediatric Medical Review
Mar 29, 2017	Supplement 55Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Nov 30, 2010	Supplement 23Efficacy (new indication or use)	Approved	Letter Label
May 25, 2006	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Sep 12, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

3 strengths and forms


Cubicin250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intravenous	Daptomycin	Discontinued
Cubicin500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intravenous	Daptomycin	DiscontinuedReference drug
Cubicin Rf500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intravenous	Daptomycin	DiscontinuedReference drug

All 48 submissions, including labeling and manufacturing supplements


May 12, 2025	Supplement 70Labeling · Standard review	Approved	Label Letter
May 8, 2025	Supplement 69Labeling · Standard review	Approved	Letter Label
Feb 23, 2022	Supplement 68Labeling · Standard review	Approved	Label Letter
Oct 26, 2021	Supplement 66Labeling · Standard review	Approved	Letter Label
Oct 26, 2021	Supplement 65Labeling · Standard review	Approved	Letter Label
Aug 26, 2020	Supplement 64Labeling · Standard review	Approved	Label Letter
Aug 26, 2020	Supplement 63Labeling · Standard review	Approved	Label Letter
Dec 3, 2018	Supplement 61Labeling · Standard review	Approved	Letter Label
Sep 1, 2017	Supplement 60Labeling · Standard review	Approved	Label Letter Label
Sep 1, 2017	Supplement 57Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Clinical Pharmacology Review Pediatric Medical Review
Jun 9, 2017	Supplement 59Labeling · Standard review	Approved	Label Letter
Mar 29, 2017	Supplement 58Labeling · Standard review	Approved	Letter Label
Mar 29, 2017	Supplement 55Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jul 7, 2016	Supplement 53Labeling · Standard review	Approved	Review Label Letter
Jul 6, 2016	Supplement 52Labeling · Priority review	Approved	Review Label
Mar 15, 2016	Supplement 51Labeling · Standard review	Approved	None posted
Sep 17, 2015	Supplement 50Labeling · Standard review	Approved	Label Letter
Aug 3, 2015	Supplement 48Labeling · Standard review	Approved	Letter Label
Jul 15, 2015	Supplement 49Manufacturing · Priority review	Approved	None posted
Feb 16, 2015	Supplement 47Manufacturing · Priority review	Approved	None posted
Nov 26, 2014	Supplement 46Labeling · Standard review	Approved	Label Letter
Sep 26, 2014	Supplement 45Manufacturing · Priority review	Approved	None posted
Nov 22, 2013	Supplement 44Labeling · Standard review	Approved	Letter Label
Nov 22, 2013	Supplement 43Labeling · Standard review	Approved	Letter Label
Jun 26, 2013	Supplement 42Manufacturing · Priority review	Approved	None posted
Mar 19, 2013	Supplement 41Manufacturing · Priority review	Approved	None posted
Oct 11, 2012	Supplement 40Labeling · Standard review	Approved	Letter Label
Jun 14, 2012	Supplement 39Labeling	Approved	Label Letter
May 22, 2012	Supplement 37Labeling	Approved	Label Letter
Oct 3, 2011	Supplement 38Labeling	Approved	Letter Label
Dec 14, 2010	Supplement 34Manufacturing · Priority review	Approved	None posted
Dec 6, 2010	Supplement 31Labeling	Approved	Letter
Nov 30, 2010	Supplement 32Labeling	Approved	Letter Label
Nov 30, 2010	Supplement 30Labeling	Approved	Letter Label
Nov 30, 2010	Supplement 27Labeling · Standard review	Approved	Letter Label
Nov 30, 2010	Supplement 24Labeling · Standard review	Approved	Letter Label
Nov 30, 2010	Supplement 23Efficacy (new indication or use)	Approved	Letter Label
Nov 30, 2010	Supplement 22Labeling · Standard review	Approved	Letter Label
Aug 13, 2010	Supplement 33Labeling	Approved	Label
Feb 10, 2009	Supplement 21Labeling · Standard review	Approved	Letter
Oct 5, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
Feb 20, 2007	Supplement 11Labeling · Standard review	Approved	Letter Label
Feb 12, 2007	Supplement 10Labeling · Standard review	Approved	Letter Label
Oct 24, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
May 25, 2006	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Mar 8, 2006	Supplement 7Labeling · Standard review	Approved	Letter Label
Oct 14, 2005	Supplement 6Labeling · Standard review	Approved	Letter Label
Sep 12, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21572
Drugs@FDA: Overview at FDA
Company: Cubist Pharmaceuticals

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