BRIDGEWATER, N.J. & VADODARA, India– Cosette Pharmaceuticals, Inc (“Cosette”), in collaboration with Aleor Dermaceuticals, a wholly owned subsidiary of Alembic Pharmaceuticals (“Alembic”; BSE: 533573), announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for an NBE version of Abreva® (Docosanol cream 10%) in a 2 gm tube and pump formats. Shipments of the product will begin imminently.
Apurva Saraf, CEO of Cosette Pharma and Pranav Amin, MD of Alembic Pharma stated, “This
approval and launch highlights our ability to successfully partner and bring important complex products to market. We look forward to launching this Private Label, Over-the-Counter product with our retail partners in the US.”
This approval represents the first ANDA approval in the pump format and Cosette plans to launch the product across the US retail channel.
