United Therapeutics Remodulin

Executive Summary

United Therapeutics will resubmit NDA for Remodulin Aug. 10 if the product receives a positive review from FDA's Cardiovascular & Renal Drugs Advisory Committee Aug. 9. The company withdrew the application for Remodulin (formerly Uniprost) for pulmonary arterial hypertension shortly before the product's July 16 user fee deadline. "Because the Aug. 9 advisory committee meeting fell outside the [Prescription Drug Use Fee Act] time period, the company was required to withdraw its NDA and will resubmit it upon a favorable advisory committee recommendation by the following day, Aug. 10," United Therapeutics said