(Reuters)—Ironwood Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration (FDA) approved its oral drug to treat a condition associated with gout.
The company’s once-daily drug, Duzallo (lesinurad and allopurinol), was approved to treat hyperuricemia in patients with gout, Ironwood said.
Duzallo combines the standard-of-care treatment, allopurinol, with Ironwood’s lesinurad to treat inefficient excretion and overproduction of uric acid in gout patients.
Duzallo’s label comes with a black box warning regarding the risk of acute renal failure, the company said.