Cosette Pharmaceuticals Announces the Approval and Launch of Metronidazole Gel USP, 1%

Launch Expands Cosette’s Generic Portfolio Through Organic Development

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for Metronidazole Gel USP, 1%.

This launch will enable Cosette to continue to build upon its unparalleled quality track record and leverage its United States based manufacturing site in Lincolnton, NC.

Apurva Saraf, President and CEO of Cosette Pharma, stated, "The continued approval and launches of our internal R&D programs highlights our commitment to world class R&D and operational excellence. We are Innovating Every Day and are committed to growing our pipeline and portfolio of products through R&D and global business development partnerships”

According to IQVIA™, U.S. market annual sales for the 12 months ended December 2022 for Metronidazole Gel USP, 1% is estimated to be approximately $17 million.

See the Full Prescribing Information and Instructions for Use for Metronidazole Gel, USP 1% at www.dailymed.com.

About Cosette Pharmaceuticals, Inc.:

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. The current products focus on complex dosage forms including topical creams, ointments, oral liquids/solutions, suppositories, and injectables. Cosette has a long history of quality manufacturing, consistent supply, and commercialization success, including two sites (New Jersey and North Carolina) supported by more than 350+ dedicated employees across all functional areas. Cosette has a fast-growing portfolio of branded pharmaceuticals, consisting of products in cardiology, women’s health and pediatrics. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. www.cosettepharma.com

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