Biocon Pharma, Carnegie Pharma gain USFDA tentative nod for Rifaximin Tablets to treat irritable bowel syndrome with diarrhea
Bangalore: Biocon has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, in partnership with Carnegie Pharmaceuticals LLC, has 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.
Irritable Bowel Syndrome is a common gastrointestinal disorder that affects the large intestine, leading to symptoms like abdominal pain, bloating, and changes in bowel habits.
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Biocon Limited, publicly listed in 2004, is a global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
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