Ixempra Kit

Treats metastatic or locally advanced breast cancer resistant. NDA 22065, held by R-Pharm US LLC. Ixabepilone.

As of Nov 14, 2026, NDA 22065 (Ixempra Kit), held by R-Pharm US LLC, was first approved by FDA on Oct 16, 2007, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2007
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

IXEMPRA is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Oct 18, 2011	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
Oct 2, 2009	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 16, 2007	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


Ixempra Kit15MG/VIAL · injectable;intravenous	Ixabepilone	RxReference drug
Ixempra Kit45MG/VIAL · injectable;intravenous	Ixabepilone	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Jan 11, 2023	Supplement 13Labeling · Standard review	Approved	Label Letter
Jan 21, 2022	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 22, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 26, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 8Manufacturing · Priority review	Approved	None posted
Oct 18, 2011	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
May 12, 2010	Supplement 5Labeling	Approved	Letter Label
May 12, 2010	Supplement 4Labeling · Standard review	Approved	Letter Label
Oct 2, 2009	Supplement 3Labeling · Standard review	Approved	Letter Label
Oct 2, 2009	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 13, 2009	Supplement 1Manufacturing	Approved	Label Letter
Oct 16, 2007	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 22065
Drugs@FDA: Overview at FDA
Company: R-Pharm US

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