Biocon Unit Gets USFDA Nod for Generic Anti-Bacterial Drug

Biocon Ltd on Tuesday announced that its wholly-owned subsidiary, Biocon Pharma, in partnership with Carnegie Pharmaceuticals LLC, has received tentative approval from the United States Food and Drug Administration (USFDA) for a generic version of an anti-bacterial medication.

In a regulatory filing, the company said the approval is for the Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg, a generic equivalent of the reference listed drug Xifaxan Tablets, 550 mg.

Rifaximin tablets are prescribed to reduce the risk of overt hepatic encephalopathy (HE) recurrence and to treat irritable bowel syndrome with diarrhoea (IBS-D) in adults.

The tentative approval from the US health regulator marks an important step for Biocon Pharma in expanding its portfolio of generic products in the United States.

“The approval underscores our commitment to providing patients with affordable and high-quality medicines,” Biocon said in the filing.

Biocon Pharma is the generic formulations arm of Biocon Ltd, which focuses on developing, manufacturing, and commercializing complex generics across key therapeutic areas for global markets.