USFDA7 Oct 2025, 08:04 am
Biocon Pharma & Carnegie Pharmaceuticals Receive Tentative U.S. FDA Approval for Rifaximin Tablets
AI Summary
Biocon Ltd. announced that its wholly owned subsidiary, Biocon Pharma Limited, in partnership with Carnegie Pharmaceuticals LLC, received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for the Abbreviated New Drug Application (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.
Key Highlights
- Biocon Pharma Limited and Carnegie Pharmaceuticals LLC received tentative approval from the U.S. FDA for Rifaximin Tablets, 550 mg.
- Rifaximin tablets are indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.
- The approval was granted for the Abbreviated New Drug Application (ANDA).
- Biocon Pharma Limited is a wholly owned subsidiary of Biocon Ltd.