May 13, 2022
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FDA approves Sun Pharmaceuticals’ generic mesalamine extended-release capsules for UC
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Sun Pharmaceutical Industries received FDA approval of its abbreviated new drug application for mesalamine extended-release capsules indicated for use in ulcerative colitis, according to a press release.
The FDA determined that, among adult patients with mildly to moderately active UC, Sun Pharmaceutical’s 500 mg product is therapeutically equivalent to Ferring Pharmaceuticals’ Pentasa 500 mg extended-release capsule, which was used as a reference product.
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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