Zydus Cadila has received final approval from USFDA to market Mesalamine Delayed- Release Tablets USP, 1.2 g in the US market. The pharma major was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda (mesalamine).
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 (mesalamine) will be produced at Moraiya Plant located at Ahmedabad. The estimated brand sales for Mesalamine Delayed-Release Tablets USP, 1.2 g is $1.145 billion, as per IMS MAT April 2017.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. 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.
