May 11, 2001
United Therapeutics Corp., a Silver Spring biotechnology firm, has agreed with the U.S. Food and Drug Administration, based in Bethesda, to extend for up to 90 days the priority review period of its new drug application for its drug to treat pulmonary arterial hypertension.
The decision was made to provide the FDA with time to review additional information submitted by United Therapeutics for the drug, called Remodulin, according to a company statement.
Shares of United Therapeutics (Nasdaq: UTHR) have plunged more than 20 percent since the delay was announced, dropping from about $15 per share to its current trading value of just over $11 per share.
United Therapeutics develops therapeutic products to combat cardiovascular, inflammatory and infectious diseases. The biotechnology company has a second drug under review, Beraprost, which is intended to treat peripheral vascular disease.
Flolan Treatment | Other PPH Treatment Options | Financial & Legal Help | What Causes PPH?
Frequently Asked Questions | Contact Us