Alembic Pharma gets approval from USFDA for Mesalamine extended-release capsules

Alembic pharmaceutical company received final approval from the US Food & Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) of Mesalamine Extended-Release Capsules USP, 0.375 g. “The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals, Inc. (Salix).

Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults,” the company said in a BSE filing. Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of US$ 133 million for twelve months ending June 2022 according to IQVIA, the company said in a release. Alembic has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from the USFDA.