Bridgewater, NJ (March 04, 2021) – Cosette Pharmaceuticals, Inc., a New Jersey-based specialty generic pharmaceutical company, has received a first cycle approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Hydrocortisone Valerate Cream USP, 0.2%. This is Cosette’s first approval for 2021 from its internally-developed pipeline of prescription pharmaceutical products.
“I am excited about our most recent approval,’’ commented Apurva Saraf, President and CEO of the Company. “This approval is further validation of Cosette’s R&D and regulatory capabilities to develop, file and receive approvals for complex products. We remain relentlessly focused on developing and launching these essential and affordable medicines for the patients we serve.” Mr. Saraf continued, “We now have 42 pharmaceutical products with 90 SKUs, including topicals, suppositories, oral solutions and oral solids, in our portfolio. We also have a strong pipeline of ANDA applications pending US FDA approval and in our R&D pipeline.”
About Cosette Pharmaceuticals, Inc.
Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with product development, manufacturing, and commercial distribution capabilities. The current products focus on complex dosage forms like creams, ointments, liquids/solutions, and suppositories. Cosette has a long history of quality manufacturing, including two dedicated manufacturing sites in the United States with 450 dedicated employees across all functional areas. The company has global partnerships to market and distribute products in various dosage forms in all distribution channels. Cosette is backed by Avista Capital Partners, a healthcare focused Private Equity firm.www.cosettepharma.com.