On Monday, Solaris Pharma Corporation (Solaris) announced that it received an abbreviated new drug application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for the first generic version of Clindagel (clindamycin).
Cosette, a generic pharma company partnered with Solaris, will manufacture the product in the United States. Generic Clindagel will be launched immediately.
Clindamycin topical gel is the generic version of Clindagel, a registered trademark of Bausch Health.
Topical Clindagel is used for the treatment of acne. It belongs to a class of drugs called lincomycin antibiotics. The drug works by slowing or stopping the growth of bacteria that cause acne.
The annual sales for clindamycin topical gel for the 12 months ending June 2021 were approximately $31 million, according to IQVIA, a company that serves the combined industries of health information technology and clinical research.
Solaris CEO Satish Pejaver said, “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,” he added.
Cosette CEO and President Apurva Saraf said, “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,” he added.
Solaris is a New Jersey-based specialty pharmaceutical company that develops and commercializes high-value drug products with limited generic competitors. Solaris is committed to developing generics that bring value to patients by providing access to quality, affordable medication.
Cosette is a generic pharmaceutical company that specializes in the areas of dermatology and allergy. It develops generics in different dosages and forms, such as creams, ointments, lotions, solutions, gels, pastes, and suppositories.
