Bicnu

NDA 17422, held by Avet Lifesciences. Carmustine.

As of Nov 14, 2026, NDA 17422 (Bicnu), held by Avet Lifesciences, was first approved by FDA on Mar 7, 1977, with 42 approved supplements and 0 published complete response letters.

First approved: Mar 7, 1977
Review: Standard
Supplements approved: 42
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Carmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors Multiple myeloma-in combination with prednisone Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 43 submissions below

Date	Submission	Status	Documents
Mar 7, 1977	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bicnu100MG/VIAL · injectable;injection	Carmustine	RxReference drug

All 43 submissions, including labeling and manufacturing supplements


Apr 30, 2021	Supplement 62Manufacturing	Approved	Letter
Mar 24, 2017	Supplement 55Labeling · Standard review	Approved	Letter Label
Apr 28, 2016	Supplement 50Labeling · Standard review	Approved	Label Letter
Nov 25, 2015	Supplement 49Manufacturing · Standard review	Approved	None posted
Jun 13, 2014	Supplement 47Manufacturing · Standard review	Approved	Review
Oct 18, 2013	Supplement 46Labeling · Standard review	Approved	Label
Sep 18, 2013	Supplement 45Manufacturing · Standard review	Approved	Review
Aug 11, 2011	Supplement 42Labeling · Standard review	Approved	Letter Label
Mar 14, 2011	Supplement 38Labeling · Standard review	Approved	Letter Label
Aug 17, 2007	Supplement 37Manufacturing	Approved	Review Letter Label
Oct 20, 2005	Supplement 36Manufacturing · Standard review	Approved	Letter
Feb 27, 2003	Supplement 35Labeling · Standard review	Approved	Letter
Sep 10, 1997	Supplement 34Labeling · Standard review	Approved	None posted
Dec 11, 1992	Supplement 31Labeling	Approved	None posted
Jul 13, 1992	Supplement 32Manufacturing · Standard review	Approved	None posted
Jun 13, 1991	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 3, 1991	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 14, 1989	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 19, 1989	Supplement 25Manufacturing · Standard review	Approved	None posted
May 17, 1988	Supplement 24Manufacturing · Standard review	Approved	None posted
Jan 12, 1988	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 26, 1987	Supplement 22Labeling	Approved	None posted
Aug 7, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 21, 1987	Supplement 8Labeling	Approved	None posted
Mar 5, 1987	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 11, 1986	Supplement 15Labeling	Approved	None posted
May 19, 1986	Supplement 18Labeling	Approved	None posted
May 19, 1986	Supplement 17Labeling	Approved	None posted
May 19, 1986	Supplement 16Labeling	Approved	None posted
Dec 10, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 8, 1984	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 3, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 13, 1984	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 17, 1984	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 29, 1983	Supplement 11Labeling	Approved	None posted
Feb 10, 1983	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 16, 1982	Supplement 7Labeling	Approved	None posted
Nov 12, 1980	Supplement 5Labeling	Approved	None posted
Oct 9, 1979	Supplement 4Labeling	Approved	None posted
Oct 9, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 15, 1978	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 22, 1977	Supplement 1Labeling	Approved	None posted
Mar 7, 1977	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17422
Drugs@FDA: Overview at FDA
Company: Avet Lifesciences

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