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

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, abdominalRead More

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