Zydus Cadila gets USFDA approval for generic form of colitis drug Lialda

Zydus Cadila said the US Food and Drug Administration has given the final approval to market the company’s Mesalamine Delayed-Release Tablets in the US market.

Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda.

Lialda is indicated for the treatment of mild to moderate ulcerative colitis.

Ulcerative colitis is a chronic inflammatory bowel disease that affects approximately 700,000 people in the United States.

The generic version of Lialda, called mesalamine, will be produced at the company’s Moraiya Plant located at Ahmedabad.

The estimated brand sales for Mesalamine Delayed-Release Tablets USP, 1.2 g is US $ 1.145 billion as per IMS MAT April 2017.

The group now has more than 115 approvals and has so far filed over 300 ANDAS since the commencement of the filing process in FY 2003-04.

Zydus Cadila employs over 20000 people worldwide.