Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin Tablets, 550 mg. The approved product is the generic version of Xifaxan Tablets, 550 mg, currently marketed in the U.S.
Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adult patients. The product is part of a therapeutic class aimed at managing gastrointestinal disorders, particularly conditions that impact patient quality of life.
The tablets will be manufactured at Zydus’ state-of-the-art production facility located at SEZ II in Ahmedabad, Gujarat. This facility is part of the Group's global supply network supporting regulated markets such as the United States.