Alembic Pharmaceuticals gets FDA final approval for ulcerative colitis generic drug

Alembic Pharmaceuticals said that it has secured final approval for its abbreviated new drug application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g from the US Food & Drug Administration (FDA).

The approved product is the generic of Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals. It is indicated for the maintenance of remission of ulcerative colitis in adult patients.

According to IQVIA, the estimated market size of Mesalamine Extended-Release Capsules USP, 0.375 g for twelve months ending June 2022 is $133 million.

Alembic Pharmaceuticals said that it has 174 ANDA approvals from the FDA so far, which include 150 final approvals and 24 tentative approvals.