BRIDGEWATER, N.J.--(BUSINESS WIRE)--Cosette Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for a generic version of MetroGel-Vaginal® (metronidazole vaginal gel 0.75%) by Bausch Health US, LLC. This product will be launched immediately.
“We are thrilled at the approval and launch of an additional affordable alternative product, serving women’s health. This FDA approval is further validation of our stellar R&D, regulatory, manufacturing, and commercial capabilities. We will continue to deliver on our commitment to provide important, high-quality, affordable medicine for patients in women’s healthcare” said Apurva Saraf, President and CEO of Cosette Pharmaceuticals.
See the Full Prescribing Information and Instructions for Use for Metronidazole Vaginal Gel 0.75%. www.dailymed.com
According to IQVIA™ data, U.S. annual sales for metronidazole vaginal gel 0.75% for the 12 months ended December 2022 totaled approximately $45 million.
MetroGel® and MetroGel-Vaginal® are registered trademarks of Galderma Holdings S.A.
About Cosette Pharmaceuticals: Cosette Pharmaceuticals, Inc. (“Cosette”) is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women’s health and dermatology. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by 300+ dedicated employees across all functional areas. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. www.cosettepharma.com
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