USFDA Gives Final Approval to Cadila Healthcare to Market Mesalamine Tablets

On Wednesday Cadila Healthcare announced that USFDA has given final approval to market Mesalamine Delayed-Released tablets USP, 1.2g in the US market. Zydus Cadila was the first to file an ANDA (Abbreviated New Drug Application) for a generic version of Lialda (mesalamine).

The generic version of Lialda (mesalamine) will be produced at Moraiya Plant located at Ahmedabad. Lialda is used 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 estimated brand sale for Mesalamine Delayed-Release tablets USP, 1.2g is USD 1.145 billion as per IMS MAT April 2017.

The group now has more than 115 approvals and has so far filler over 300 ANDAs since the commencement of the filling process in FY 2003-2004.