Dermavant Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age...
Roivant Sciences Ltd. (ROIV)
Company Research
Source: Yahoo! Finance
- FDA PDUFA Action Expected in Q4 2024 - LONG BEACH, Calif. & BASEL, Switzerland, April 29, 2024 BUSINESS WIRE )--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older. The Prescription Drug User Fee Act ("PDUFA") action date assigned by the Agency is in Q4 2024. VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD. VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation being studied in the ADORING Phase
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ROIV
Earnings
- 2/13/24 - Beat
ROIV
Sec Filings
- 4/30/24 - Form 4
- 4/26/24 - Form 4
- 4/26/24 - Form 4
- ROIV's page on the SEC website