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Biotechnology News Magazine

Solaris Pharma Receives Approval for First Generic Version of Clindagel®

Clindagel®: Solaris Pharma Corporation (“Solaris” or the “Company”) announced today that the Company has received an abbreviated new drug application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA” or “Agency”) for the first generic version of Clindagel® (clindamycin phosphate EQ 1%).

This product will be manufactured in the United States by Cosette, Solaris’ manufacturing partner. The product will be launched immediately.

Clindamycin phosphate EQ 1% topical gel is the generic version of Clindagel, a registered trademark of Bausch Health. According to IQVIA™ data, U.S. annual sales for clindamycin topical gel for the 12 months ending June 2021 were approximately $31 million.

“Solaris is pleased to provide patients access to this first-to-market generic of Clindagel. This approval validates our stellar in-house development, regulatory and commercial capabilities, by not only getting timely Agency approval, but also by orchestrating a day-1 launch. With a robust pipeline of potential first-to-market products in development, Solaris will continue to deliver on our commitment to provide high-quality, affordable medicine to patients,” said Satish Pejaver, Ph.D., Solaris’ Chief Executive Officer.

“We are excited to support Solaris on this approval and be their reliable manufacturing partner on this product. This is another milestone in Cosette’s ability to successfully partner and manufacture complex topical products right here in the United States, while ensuring access to safe, effective and affordable drugs for the patients we serve,” said Apurva Saraf, Cosette Pharmaceuticals’ President & Chief Executive Officer.

Biotechnology News Magazine
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