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Vyne Therapeutics Inc
VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update
Business
Feb 1 2021
5 min read

VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update

AMZEEQ® label update includes new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. acnes”) to develop resistance to minocycline

BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration (“FDA”) to include new information in the product label for AMZEEQ® (minocycline) topical foam, 4% referencing the low propensity of P. acnes strains to develop resistance to minocycline, the active ingredient in AMZEEQ. AMZEEQ is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.

Specifically, the FDA-approved AMZEEQ label now provides that with respect to resistance, P. acnes strains displayed a low propensity for the development of resistance to minocycline, with spontaneous mutation frequencies occurring