Zydus secures tentative USFDA approval for Rifaximin Tablets 550 mg
The tablets, used for treating IBS-D in adults, will be manufactured at the company’s SEZ II facility in Ahmedabad
Zydus Lifesciences, along with its subsidiaries and affiliates (collectively referred to as “Zydus”), has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin Tablets, 550 mg. The reference listed drug (RLD) is Xifaxan Tablets, 550 mg.
According to the company, Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. These tablets will be produced at the group’s manufacturing facility located at SEZ II, Ahmedabad.
As per IQVIA MAT March 2025 data, the annual sales of Rifaximin tablets in the United States were recorded at USD $2,672.9 million.
Zydus stated that this approval adds to its growing portfolio of abbreviated new drug applications (ANDAs). With this tentative approval, the group now has 427 approvals and has filed a total of 492* ANDAs since the initiation of the filing process in financial year 2003–04.