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 24 tentative approvals from the FDA.
Alembic Pharmaceuticals received FDA approval of its abbreviated new drug application for mesalamine extended-release capsules.
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According to the FDA, the most common adverse events associated with mesalamine include diarrhea, headache, nausea, abdominal pain, dyspepsia, vomiting and rash.
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