India, June 2 -- Zydus Lifesciences Limited (along with its subsidiaries and affiliates, collectively referred to as "Zydus") has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Rifaximin Tablets, 550 mg—a generic version of Xifaxan® Tablets, 550 mg.
The tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults and will be manufactured at Zydus' facility in SEZ II, Ahmedabad.
As per IQVIA MAT data for March 2025, Rifaximin Tablets (550 mg) recorded annual sales of USD $2,672.9 million in the U.S. market.
With this approval, Zydus now has 427 regulatory approvals and has filed 492 Abbreviated New Drug Applications (ANDAs) since it began the filing p...