Alembic Pharmaceuticals Receives USFDA Final Approval for Mesalamine Extended-release Capsules Usp, 0.375 G.

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3rd November 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today 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.

Mesalamine Extended-Release Capsules USP, 0.375 g, has an estimated market size of US$ 133 million 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