Azelaic Acid

Treats mild-to-moderate inflammatory acne vulgaris. Sold as Azelex, Finacea. Every FDA application for this active ingredient: 3 branded and 6 generic.

As of Nov 15, 2026, FDA lists 9 applications for Azelaic Acid (sold as Azelex, Finacea), first approved Sep 13, 1995, with 1 new use approved and 0 published complete response letters.

First approved: Sep 13, 1995
Applications: 9
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $11.2M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Azelaic Acid	Part D	$7.3M	-14%	52,659
Finacea	Part D	$2.4M	-13%	2,532
Azelex	Part D	$1.5M	+1%	1,083

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

AZELAIC ACID 15% GEL: $0.460 per GMGeneric · -30% in a year
FINACEA 15% FOAM: $8.34 per GMBrand · +0% in a year

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone SkinAcne-prone Skin, Skin Disease · WiQo S.p.A.	Not applicable	Recruiting	Oct 8, 2026
Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing RadiationBreast Cancer · Virginia Commonwealth University	Phase 1	Recruiting	May 11, 2025
Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)Central Centrifugal Cicatricial Alopecia · Wake Forest University Health Sciences	Early phase 1	Active, not recruiting	Jun 13, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 13, 1995	AzelexNDA 20428 · New molecular entity	Almirall	16	Marketed
Dec 24, 2002	FinaceaNDA 21470 · New dosage form	Leo Pharma As	11	Marketed
Jul 29, 2015	FinaceaNDA 207071 · New dosage form	Leo Pharma As	2	Marketed
Nov 19, 2018	Azelaic AcidANDA 204637	Glenmark Speclt	2	Marketed
Nov 19, 2018	Azelaic AcidANDA 208011	Actavis Labs Ut Inc	2	Marketed
Nov 19, 2018	Azelaic AcidANDA 208724	Encube	2	Marketed
Aug 23, 2019	Azelaic AcidANDA 210549	Sun Pharma Canada	2	Marketed
Oct 7, 2020	Azelaic AcidANDA 210928	Aurobindo Pharma USA	0	Discontinued
—	Azelaic AcidANDA 212581	Taro Pharm Inds Ltd	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA