Zydus Cadila receives final approval from US FDA for Mesalamine Extended-Release capsules

Zydus Cadila has received the final approval from the US Food and Drug Administration (FDA) to market Mesalamine Extended-Release capsules in the strength of 0.375 g, (US RLD: Apriso), the company notified in a statement.

Mesalamine Extended-Release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, it further said.