FDA approves Alembic Pharmaceuticals’ generic mesalamine extended-release capsules for UC

Alembic Pharmaceuticals received FDA approval of its abbreviated new drug application for mesalamine extended-release capsules indicated for maintenance of remission in ulcerative colitis, according to a manufacturer release.The FDA determined that, among adult patients with mildly to moderately active UC, Alembic Pharmaceutical’s 0.375 g product is therapeutically equivalent to Salix Pharmaceuticals’ Apriso extended-release capsule, which was used as a reference product. This approval adds to a considerable tally of ANDA approvals for Alembic, including 150 final approvals and 24Read More

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