Solaris obtains FDA green light for generic Clindagel

The  Food and Drug Administration has given its blessing to Solaris for the first generic version of Bausch Health’s Clindagel (clindamycin phosphate EQ 1%).

“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, Solaris’ CEO.

This product, which is used to treat acne, will be manufactured in the United States by Cosette, Solaris’ manufacturing partner. It will be launched immediately.

“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 and CEO.

Clindagel has a market value of roughly $31 million for the 12 months ended June 2021, according to IQVIA.