Biocon Pharma Limited, a wholly owned subsidiary of Biocon Ltd, has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. The approval has been granted in partnership with Carnegie Pharmaceuticals LLC.
In the exchange filings, the company shared, “This is to inform you that Biocon Pharma Limited, a wholly owned subsidiary of the Company, in partnership with Carnegie Pharmaceuticals LLC, received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for the ANDA for Rifaximin Tablets, 550 mg.”
Rifaximin Tablets are a rifamycin-class antibacterial medicine used to reduce the risk of recurrence of overt hepatic encephalopathy (HE) and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
This approval marks another milestone for Biocon Pharma in expanding its portfolio of complex generics in the U.S. market.
