Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for 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. It works inside the bowels to reduce inflammation and other symptoms of the disease.
Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of 133 million USD for twelve months ending June 2022 according to IQVIA.
Alembic has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from USFDA.
