UTT drug gets FDA approval
United Therapeutics Corp. got approval from Food and Drug Administration for their fourth drug to treat pulmonary arterial hypertension.
The FDA, on Thursday gave approval for the Silver Spring biotech’s inhaled version of the drug. The approval has helped UTT shares to get a rise in the market by $10.24 at NASDAQ. The company is planning to market the product in September. They are also planning to market the new tablet version of the drug called Adcirca, to treat pulmonary arterial hypertension.
The CEO and chairwoman Martine Rothblatt said, “We are thrilled to have a fourth approval from the FDA for treatment of this serious cardio-pulmonary condition”.
The FDA will affix instructions for post marketing changes and studies. The instructions might give importance for making the inhalant device more patient-friendly by October 31, 2010. There might be a suggestion to make a survey on the basis of risks found in oropharyngeal and pulmonary toxicities among Tyvaso patients by December 15, 2013.