Acanya, Onexton

Treats acne vulgaris. NDA 50819, held by Bausch. Benzoyl Peroxide; Clindamycin Phosphate.

As of Nov 14, 2026, NDA 50819 (Acanya, Onexton), held by Bausch, was first approved by FDA on Oct 23, 2008, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 23, 2008
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Nov 24, 2014	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 23, 2008	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Label Letter

Products

2 strengths and forms


Acanya2.5%;EQ 1.2% BASE · gel;topical	Benzoyl Peroxide; Clindamycin Phosphate	RxReference drug
Onexton3.75%;EQ 1.2% BASE · gel;topical	Benzoyl Peroxide; Clindamycin Phosphate	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 29Manufacturing	Approved	Letter Label
Feb 21, 2020	Supplement 24Labeling · Standard review	Approved	Label Letter
Feb 21, 2020	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 25, 2016	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 19, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 8, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 10, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 24, 2014	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 18, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 28, 2014	Supplement 10Labeling · Standard review	Approved	Letter Label
Dec 18, 2012	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 18, 2010	Supplement 3Labeling	Approved	Letter Label
Jun 23, 2010	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 23, 2008	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 50819
Drugs@FDA: Overview at FDA
Company: Bausch Health

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