Savient Pharmaceuticals Inc. said Monday that it resubmitted an application to have its gout drug approved by the Food and Drug Administration.
Krystexxa, or pegloticase, is meant to treat gout in patients who have already tried other drugs.
Paul Hamelin, president of Savient, said the latest application should address the manufacturing concerns the FDA raised last summer. The application also includes a safety update from the studies that were ongoing at the time of the previous 120-day safety update, the company said.
Hamelin said the company expects a potential approval in mid-September.
Shares of Savient fell a penny to $14.89 in afternoon trading.