FDA Approves Generic Mesalamine Extended Release Capsules for Ulcerative Colitis

The FDA has approved an Abbreviated New Drug Application (ANDA) from Sun Pharmaceutical Industries Limited for generic Mesalamine Extended Release Capsules 500 mg.

The approval of the ANDA for the generic product was based on the reference product Pentasa Extended Release Capsules, 500mg.

Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis. Mesalamine is a locally-acting aminosalicylate indicated for the maintenance treatment of diarrhea, upper abdominal pain, nausea, nasopharyngitis, flu or flu-like remission of ulcerative colitis in adults.

The treatment acts inside the bowels to lower inflammation and other symptoms of ulcerative colitis. The mechanism of action of mesalamine is unknown but appears to be local to the intestinal mucosa rather than systemic.

Mesalamine is available in delayed-release and enteric coated tablets as well as in delayed- and extended-release capsules. The most common adverse events (incidence ≥3%) are headache, diarrhea, upper abdominal pain, nausea, nasopharyngitis, flu or flu-like remission of ulcerative colitis in adults, illness, and sinusitis.

In a statement, Sun Pharma said that per March 2022 IQVIA Health data, Pentasa Extended Release Capsules had annual sales of approximately $213 million in the United States.

Reference

Sun Pharma Announces US FDA Approval for Generic Mesalamine Extended Release Capsules. Sun Pharmaceutical Industries Limited. News release. May 12, 2022. https://sunpharma.com/wp-content/uploads/2022/05/Press-Release-US-FDA-approval-for-generic-Mesalamine-Extended-Release-Capsules.pdf