Betamethasone Valerate

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Sold as Valisone, Beta-Val, Betaderm, Betamethasone Valerate, Betatrex and 1 more. Every FDA application for this active ingredient: 15 branded and 18 generic.

As of Nov 15, 2026, FDA lists 33 applications for Betamethasone Valerate (sold as Valisone, Beta-Val, Betaderm and others), first approved Sep 2, 1967, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 2, 1967
Applications: 33
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $8.8M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Betamethasone Valerate	Part D	$8.8M	-1%	151,199

Clinical Trials

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


New Topical Treatment in Patchy Alopecia AreataAlopecia Areata · Sohag University	Not applicable	Not yet recruiting	Jul 10, 2026
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot StudyUrinary Tract Infection · Baylor College of Medicine	Phase 4	Recruiting	Apr 2, 2026
Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque PsoriasisPsoriasis · Assiut University	Not applicable	Not yet recruiting	Jan 26, 2026
New Topical Treatment in Plaque PsoriasisPlaque Psoriasis · Sohag University	Not applicable	Not yet recruiting	Aug 11, 2025
Using a Contact Dermatitis Model With Biologic Medications to Study Skin InflammationSkin Inflammation, Allergic Contact Dermatitis · Wei-Che Ko	Phase 2 / Phase 3	Active, not recruiting	Sep 10, 2022
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)Preterm Birth, Premature Birth · McMaster University	Phase 4	Recruiting	Nov 9, 2021

Applications

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


Sep 2, 1967	ValisoneNDA 16322 · New active ingredient	Schering	16	Discontinued
Feb 17, 1969	ValisoneNDA 16740 · New dosage form	Schering	15	Discontinued
Jan 10, 1973	ValisoneNDA 16932 · New dosage form	Schering	11	Discontinued
Mar 24, 1983	Beta-ValNDA 18642	Cosette Pharms Nc	19	Marketed
Jun 30, 1983	BetadermNDA 18839	Roaco	0	Discontinued
Aug 31, 1983	Betamethasone ValerateNDA 18861	Fougera	9	Marketed
Aug 31, 1983	BetatrexNDA 18862	Savage Labs	7	Discontinued
Aug 31, 1983	Betamethasone ValerateNDA 18865	Fougera	8	Marketed
Aug 31, 1983	Betamethasone ValerateNDA 18866	Fougera	8	Marketed
Aug 31, 1983	BetatrexNDA 18867	Savage Labs	7	Discontinued
Aug 31, 1983	BetatrexNDA 18863	Savage Labs	8	Discontinued
Oct 10, 1984	ValnacANDA 70050	Actavis Mid Atlantic	15	Marketed
Oct 10, 1984	Betamethasone ValerateANDA 70051	Actavis Mid Atlantic	15	Marketed
May 14, 1985	Betamethasone ValerateANDA 70062	Sun Pharma Canada	12	Discontinued
Jun 27, 1985	Beta-ValANDA 70072	Cosette Pharms Nc	12	Discontinued
Jul 31, 1985	Betamethasone ValerateANDA 70052	Pharmazone	11	Marketed
Dec 19, 1985	Beta-ValANDA 70069	Cosette Pharms Nc	8	Marketed
Jan 6, 1988	DermabetANDA 72041	Sun Pharma Canada	10	Marketed
Apr 22, 1988	Betamethasone ValerateANDA 71883	Teva Pharms	6	Discontinued
Sep 8, 1994	Betamethasone ValerateANDA 70053	Perrigo New York	1	Discontinued
Feb 28, 1999	LuxiqNDA 20934 · New dosage form	Quagen	10	Discontinued
Nov 26, 2012	Betamethasone ValerateANDA 78337	Padagis Israel	0	Marketed
May 24, 2017	Betamethasone ValerateANDA 207144	Ingenus Pharms LLC	0	Discontinued
May 24, 2017	Betamethasone ValerateANDA 208204	Taro	0	Marketed
Apr 18, 2023	Betamethasone ValerateANDA 210639	Xiromed	0	Marketed
Aug 22, 2024	Betamethasone ValerateANDA 215832	Alembic	0	Marketed
—	Betamethasone ValerateNDA 18860	Pharmaderm	0	Discontinued
—	Betamethasone ValerateNDA 18864	Pharmaderm	0	Discontinued
—	Betamethasone ValerateNDA 18870	Pharmaderm	0	Discontinued
—	Betamethasone ValerateANDA 70484	Pharmafair	0	Discontinued
—	Betamethasone ValerateANDA 70485	Pharmafair	0	Discontinued
—	Betamethasone ValerateANDA 70486	Pharmafair	0	Discontinued
—	Betamethasone ValerateANDA 71478	Perrigo New York	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