Posts Tagged ‘complete response letter’

March 25th, 2013

Once Again FDA Rejects Oral Treprostinil for Pulmonary Arterial Hypertension

For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH). The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA. “We remain confident that oral treprostinil will play […]