USFDA2 Jun 2025, 08:09 am
Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg
AI Summary
Zydus Lifesciences Ltd has received tentative approval from the USFDA for Rifaximin Tablets, 550 mg (USRLD: Xifaxan® Tablets, 550 mg). The tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The production will take place at the Group’s manufacturing site at SEZ II, Ahmedabad. The group now has 427 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04. Rifaximin tablets had annual sales of USD $2672.9 mn in the United States (IQVIA MAT March 2025).
Key Highlights
- Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg
- Rifaximin tablets are indicated for the treatment of IBS-D in adults
- The tablets will be produced at the Group’s manufacturing site at SEZ II, Ahmedabad
- Zydus has 427 approvals and has filed 492 ANDAs since FY 2003-04
- Rifaximin tablets had annual sales of USD $2672.9 mn in the United States (IQVIA MAT March 2025)