Sun Pharma Gets U.S. FDA Nod For Generic Drug Mesalamine Extended Release Capsules

Sun Pharmaceutical Industries Ltd. on Thursday said it has received final approval from the U.S. health regulator for Mesalamine extended-release capsules, used to treat bowel disease, in the American market.

The company has received approval from the U.S. Food and Drug Administration for the product, a generic version of Pentasa extended release capsules (500 mg), the Mumbai-based drug major said in a statement.

As per March 2022 IQVIA Health data, Pentasa had annualised sales of around $213 million in the U.S. market.