Cosette Pharmaceuticals Launches Metronidazole Vaginal Gel 0.75%, AB-rated to MetroGel-Vaginal^® 0.75%

Further expands Cosette’s portfolio in affordable women’s healthcare

Metronidazole Gel 0.75% (Graphic: Business Wire)

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

Contacts

Serge Ilin-Schneider: bd@cosettepharma.com
Kian Kazemi: sales@cosettepharma.com

Industry:

Cosette Pharmaceuticals, Inc.

Details

Headquarters: Bridgewater, New Jersey, USA

Website: https://cosettepharma.com

CEO: Apurva Saraf

Employees: 350

Organization: PRI

Release Summary

Cosette Pharmaceuticals Launches Metronidazole Vaginal Gel 0.75%, AB-rated to MetroGel-Vaginal® 0.75%

Release Versions

Hashtags

#pharmaceuticalindustry

#pharmaceuticalmanufacturing

#pharmaceuticals

Contacts

Serge Ilin-Schneider: bd@cosettepharma.com
Kian Kazemi: sales@cosettepharma.com

Social Media Profiles

Cosette Linkedin

More News From Cosette Pharmaceuticals, Inc.

Cosette Pharmaceuticals Appoints Jeff Neubig as Vice President, Quality and Regulatory Affairs

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Cosette Pharmaceuticals, Inc., a U.S.-based, fully integrated, pharmaceutical company, announced today that it has appointed Jeff Neubig as Vice President, Quality and Regulatory Affairs. In this critical role, Jeff will lead Cosette’s best-in-class quality and regulatory affairs organizations, maintaining the company’s rigorous quality standards and further establishing Cosette’s strong position as a respected and reliable supplier of high-quality medicines....

Cosette Pharmaceuticals Announces Acquisition of Mayne Pharma, Transforming Company into a Leader in Women’s Health and Dermatology

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Cosette Pharmaceuticals, Inc., a U.S.-based, fully integrated, pharmaceutical company, announced today that it has entered into a definitive agreement to acquire all the outstanding shares of Mayne Pharma Group Limited (ASX: Ticker MYX) (Mayne Pharma) at AUD$7.40/share for a total consideration of approximately USD $430 Million. The Boards of Directors of both companies have approved the transaction and Mayne Pharma’s Board of Directors has unanimously recomm...