Zydus Cadila gets FDA approval for Mesalamine Extended-Release Capsules
Zydus Cadila said that it has secured final approval from the US Food and Drug Administration (FDA) to market Mesalamine Extended-Release Capsules in the strength of 0.375g.
Mesalamine Extended-Release capsules are approved for the maintenance of remission of ulcerative colitis in adult patients.
Zydus Cadila said that the ulcerative colitis drug will be manufactured at its formulation manufacturing facility located at the SEZ, Ahmedabad.
The Indian pharma company currently has 320 approvals and has to date, filed more than 400 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.