Enforcement Report - Week of June 7, 2023
Glenmark gets USFDA nod for generic drug with 180-day exclusivity
DURHAM, N.C. and COPENHAGEN, Denmark, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that EPI Health, a Novan Company, and MC2 Therapeutics presented data from a previously unpublished subgroup analysis of the U.S. Phase 3 pivotal study of WYNZORA® Cream at the Skin of Color Update 2022 Conference held September 9-11, 2022, in New York, NY.
Enforcement Report - Week of July 6, 2022
Mumbai: The United States Food and Drug Administration (U.S. FDA) has granted Glenmark Pharmaceuticals Inc., USA tentative approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005 per cent and 0.064 per cent, the generic version of Enstilar®1 Foam, 0.005 per cent and 0.064 per cent, by Leo Pharma AS.
CHARLESTON, SC and COPENHAGEN, DENMARK / ACCESSWIRE / November 9, 2021 / EPI Health, LLC, a specialty pharmaceutical company committed to delivering innovative prescription therapies to dermatologists and MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard within topical therapies for plaque psoriasis today announced that Express Scripts, a large pharmacy benefit manager (PBM) has provided access to Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older on its National Preferred, National Preferred Flex, High Performance, and Basic formularies.
BALLERUP, Denmark, and Madison, N.J. OCT. 22, 2020 – LEO Pharma A/S today announced the U.S. Food and Drug Administration (FDA) has approved a U.S. Prescribing Information (USPI) update for Enstilar® (calcipotriene and betamethasone dipropionate) Foam to include data on long-term use in adults with plaque psoriasis.
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