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Treats inflammatory lesions of rosacea. Sold as Epsolay. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Benzoyl Peroxide (sold as Epsolay), first approved Apr 22, 2022, with 0 new uses approved and 0 published complete response letters.
First approved: Apr 22, 2022
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $365K
First approved in Japan: Dec 26, 2014
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Epsolay
Part D
$365K
-21%
304
Approvals in Japan (PMDA)
First approved in Japan 88 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Bepio Wash, new approvalA drug with a new dosage in an additional dosage form indicated for the treatment of acne vulgaris. · Maruho Co., Ltd. · Mar 27, 2025
Bepio, new ingredientA drug with a new active ingredient indicated for the treatment of acne vulgaris. · Maruho Co., Ltd. · Dec 26, 2014
Clinical Trials
28 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
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