New Delhi: Drug firm Zydus Cadila said it has received the US health regulator’s nod to market mesalamine tablets, used for the treatment of ulcerative colitis.
The USFDA has given its final approval to market mesalamine delayed-release tablets USP 1.2 g in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for the generic version of Lialda (mesalamine), the company said in a BSE filing.
The company will manufacture the product at its Moraiya facility in Ahmedabad.
The Gujarat-based group has more than 115 approvals and has filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.