Alembic Pharmaceuticals gets final approval for Mesalamine Extended-Release Capsules from USFDA

02 Nov 2022 Evaluate

Alembic Pharmaceuticals 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, have an estimated market size of $133 million for twelve months ending June 2022 according to IQVIA. The company has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

Alembic Pharma Share Price

771.10 0.90 (0.12%)
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