Alembic Pharmaceuticals receives USFDA approval for Mesalamine ER Capsules

4 Nov 2022 , 01:31 AM

Alembic Pharmaceuticals 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 0375 g The approved ANDA is therapeutically equivalent to the reference listed drug product RLD Apriso Extended-Release Capsules 0375 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 0375 g have 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