Wednesday, June 4, 2025

Zydus gets U.S. FDA tentative nod for Rifaximin tablets 550 mg 

Generic drugmaker Zydus Lifesciences has received tentative approval from the U.S. Food and Drug Administration (FDA) for Rifaximin Tablets, 550 mg. The product is indicated for treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets had annual sales of $2672.9 million in the United States, the company said citing IQVIA MAT March 2025 numbers. The product will be produced at the Group’s manufacturing site at SEZ II, Ahmedabad, it said on Monday.

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