Biocon arm receives tentative USFDA approval for tablets used to treat stomach ailments

Shares of Biocon Ltd. are witnessing volatile moves on Tuesday, October 7, after its wholly-owned subsidiary received tentative approval from the US Food and Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for the Rifaximin tablets, 550 mg.

Biocon Pharma Ltd., Biocon's arm, partnered with Carnegie Pharmaceuticals for the drug.

The tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy recurrent and to treat irritable bowel syndrome with diarrhoea in adults, according to Biocon.

In an earlier interaction with CNBC-TV18, the management of Biocon had highlighted that it is well-positioned to drive long-term value creation in FY26 and beyond, with strong progress across all its businesses and increased capacity from US acquisitions by Syngene and Biocon Generics.

Shares of Biocon had opened higher on Tuesday, but are currently off opening highs, trading 0.3% higher at $348.65. The stock has declined 4% in the last one month, and is down over 5% on a year-to-date basis.