Biocon Pharma Limited, a subsidiary of Biocon, has received tentative approval from the US FDA for its ANDA for Rifaximin Tablets, 550 mg. The drug is a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and for treating irritable bowel syndrome with diarrhea (IBS-D) in adults. This tentative approval marks a significant milestone for Biocon in expanding its product offerings in the US market.
US FDA Approval for Rifaximin Tablets
Biocon Pharma Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg.
Rifaximin Tablet Uses
Rifaximin tablets are a rifamycin antibacterial. The tablets are indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and for treating irritable bowel syndrome with diarrhea (IBS-D) in adults.
This approval represents progress for Biocon in the pharmaceutical industry and will allow for future market expansion.
Source: BSE
