Hexalen

NDA 19926, held by Eisai Inc. Altretamine.

As of Nov 13, 2026, NDA 19926 (Hexalen), held by Eisai Inc, was first approved by FDA on Dec 26, 1990, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 26, 1990
Review: Priority
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 26, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hexalen50MG · capsule;oral	Altretamine	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Aug 29, 2014	Supplement 25Manufacturing · Priority review	Approved	None posted
Jan 9, 2014	Supplement 24Manufacturing · Priority review	Approved	None posted
Feb 28, 2013	Supplement 23Manufacturing · Priority review	Approved	None posted
Jul 11, 2001	Supplement 17Manufacturing · Priority review	Approved	None posted
Oct 19, 1999	Supplement 16Manufacturing · Priority review	Approved	None posted
Apr 11, 1997	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 11, 1995	Supplement 14Manufacturing · Priority review	Approved	None posted
Jun 23, 1995	Supplement 13Manufacturing · Priority review	Approved	None posted
Jul 26, 1994	Supplement 12Manufacturing · Priority review	Approved	None posted
Mar 12, 1993	Supplement 11Manufacturing · Priority review	Approved	None posted
Feb 10, 1993	Supplement 10Labeling	Approved	None posted
Jan 14, 1993	Supplement 5Manufacturing · Priority review	Approved	None posted
Jan 14, 1993	Supplement 3Manufacturing · Priority review	Approved	None posted
May 29, 1992	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 19, 1992	Supplement 8Manufacturing · Priority review	Approved	None posted
Oct 22, 1991	Supplement 7Manufacturing · Priority review	Approved	None posted
Sep 20, 1991	Supplement 6Manufacturing · Priority review	Approved	None posted
Apr 26, 1991	Supplement 4Manufacturing · Priority review	Approved	None posted
Mar 14, 1991	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 26, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19926
Drugs@FDA: Overview at FDA
Company: Eisai

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