Latest news with #RifaximinTablets
The Hindu
3 days ago
- Business
- The Hindu
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.
Time of India
3 days ago
- Business
- Time of India
Zydus gets USFDA nod for generic IBS-D treatment drug
Zydus Lifesciences on Monday said it has received approval from the US health regulator to market a drug for the treatment of irritable bowel syndrome with diarrhoea in adults. The company has received tentative approval from the US Food and Drug Administration (USFDA) for Rifaximin Tablets (550 mg), the drug manufacturing firm said in a regulatory filing. Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea ( IBS-D ) in adults. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Access all TV channels anywhere, anytime Techno Mag Learn More Undo As per the IQVIA MAT March sales data, Rifaximin tablets had an annual sales of USD 2,672.9 million in the US. Shares of Zydus Lifesciences were trading at Rs 926.05 apiece, 0.41 per cent down from previous close, on BSE.
Business Upturn
4 days ago
- Business
- Business Upturn
Zydus receives tentative USFDA approval for Rifaximin Tablets, 550 mg
By Aman Shukla Published on June 2, 2025, 08:12 IST Zydus Lifesciences Limited, 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 its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. The approved product is a generic version of Xifaxan® Tablets, 550 mg, which is indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be manufactured at the company's SEZ II facility in Ahmedabad, India. According to IQVIA MAT data for March 2025, Rifaximin Tablets, 550 mg, recorded annual sales of approximately USD $2,672.9 million in the U.S. market. With this tentative approval, Zydus now has a total of 427 ANDA approvals. Since beginning its ANDA filings in the financial year 2003–04, the company has submitted 492 ANDAs to date. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
