BRIDGEWATER, N.J.– Cosette Pharmaceuticals, Inc. (“Cosette”) announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for Metronidazole Gel USP, 1%.
This launch will enable Cosette to continue to build upon its unparalleled quality track record and leverage its United States based manufacturing site in Lincolnton, NC.
Apurva Saraf, President and CEO of Cosette Pharma, stated, “The continued approval and launches of our internal R&D programs highlights our commitment to world class R&D and operational excellence. We are Innovating Every Day and are committed to growing our pipeline and portfolio of products through R&D and global business development partnerships”
According to IQVIA™, U.S. market annual sales for the 12 months ended December 2022 for Metronidazole Gel USP, 1% is estimated to be approximately $17 million.