Archive · 2 Jun 2025
Zydus Life Receives USFDA Approval for IBS Drug, Revenue Up
Zydus Lifesciences got a green light from the US FDA for their Rifaximin tablets, a medicine for adults with irritable bowel syndrome with diarrhea.
This means they can sell the medicine in the US, though it's a tentative approval for now.
The medicine will be made in Ahmedabad.
The company also got a fast track label for another drug used for amyotrophic lateral sclerosis (ALS), potentially speeding up its approval process.
While the company's revenue increased, its profit dipped slightly, and shares were trading slightly lower.
Zydus Lifesciences received tentative USFDA approval for Rifaximin tablets.
The tablets are for treating irritable bowel syndrome with diarrhea.
The tablets will be produced in Ahmedabad.
The USFDA granted a fast track designation for Usnoflast drug.
Zydus Life's revenue increased by 24% in the fourth quarter.
- Who
- Zydus Lifesciences
- What
- Tentative USFDA approval for Rifaximin tablets; fast track designation for Usnoflast drug; financial results
- When
- June 2, (approval date)
- Where
- Ahmedabad (manufacturing site), US market
- Why
- To provide a treatment for irritable bowel syndrome with diarrhea and other potential treatments
- Drug
- Rifaximin tablets, 550 mg
- Indication
- Irritable bowel syndrome with diarrhea in adults
- Approval Type
- Tentative
- Manufacturing Site
- SEZ II, Ahmedabad
- US Market Sales (Rifaximin tablets)
- $2,672.9 million (2025)
- Fast Track Designation
- Usnoflast drug for ALS
- Q4 Revenue Increase
- 24%
- Net Profit Decline
- 1%