Alembic Pharmaceuticals gets FDA final approval for ulcerative colitis generic drug

Alembic Pharmaceuticals gets FDA final approval for ulcerative colitis generic drug

Alembic Pharmaceuticals said that it has secured final approval for its abbreviated new drug application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g from the US Food & Drug Administration (FDA). The approved product is the generic of Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals. It is indicated for the maintenance of remission of […]