Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Epsolay® for the Treatment of Inflammatory Lesions of Rosacea
Sol-Gel Technologies Ltd. (SLGL)
Last sol-gel technologies ltd. earnings: 11/13 07:05 am
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Source: GlobeNewswire
- PDUFA Goal Date Set for April 26, 2021 - Potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product NESS ZIONA, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that its New Drug Application (NDA) for Epsolay® (benzoyl peroxide), an investigational proprietary topical cream for the treatment of inflammatory lesions of rosacea, containing 5% encapsulated benzoyl peroxide, has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for Epsolay is April 26, 2021. The NDA filing is based on two positive, identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of Epsolay compared
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SLGL
Earnings
- 11/9/23 - Beat
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Sec Filings
- 4/8/24 - Form SC
- 4/4/24 - Form 424B3
- 4/2/24 - Form EFFECT
- SLGL's page on the SEC website