Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets

Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy

Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, 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 antibacterial indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.