Veregen

NDA 21902, held by Ani Pharms. Sinecatechins.

As of Nov 14, 2026, NDA 21902 (Veregen), held by Ani Pharms, was first approved by FDA on Oct 31, 2006, with 12 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2006
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Limitations of Use Safety and effectiveness of Veregen have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses. 1.1 Indication Veregen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Dec 19, 2007	Supplement 2Efficacy (new indication or use)	Approved	Letter Label
Oct 31, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Veregen15% · ointment;topical	Sinecatechins	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Dec 19, 2018	Supplement 33Labeling · Standard review	Approved	Letter Label
Jul 8, 2016	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 6, 2015	Supplement 29Manufacturing · Standard review	Approved	None posted
May 31, 2013	Supplement 27Manufacturing · Standard review	Approved	None posted
May 9, 2013	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 1, 2013	Supplement 26Manufacturing · Standard review	Approved	Letter
Nov 19, 2012	Supplement 25Labeling · Standard review	Approved	Label Letter
Sep 18, 2008	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 13, 2008	Supplement 7Manufacturing	Approved	None posted
Dec 19, 2007	Supplement 2Efficacy (new indication or use)	Approved	Letter Label
Jun 27, 2007	Supplement 3Manufacturing	Approved	None posted
Jun 1, 2007	Supplement 1Labeling · Standard review	Approved	Letter Label
Oct 31, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21902
Drugs@FDA: Overview at FDA
Company: ANI 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