US FDA gives final approval for Mesalamine extended-release capsules

The US Food and Drug Administration (FDA) today gave final approval to Alembic Pharma for its Abbreviated New Drug Application (ANDA) for Mesalamine extended-release capsules USP, 0.375 g, a statement from Alembic Pharma has notified.

According to the statement, Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Apriso extended-release capsules, 0.375 g, of Salix Pharma.