On Friday, United Therapeutics Corp. revealed that it is all set to withdraw a European application for its high blood pressure treatment Tyvaso, citing an objection put forward by regulators over clinical practices at testing sites.
As has been confirmed by the company, the Committee for Medicinal Products for Human Use of the European Medicines Agency stated noncompliance at testing cites. The issue would now preclude a recommendation for approval.
The application for approval was sent in by United Therapeutics in December 2008.
The revenue growth targets, as has been shared by the company, are completely unaffected by the development, and withdrawal of the drug application in Europe will not hurt the earnings or reputation of the firm.
Approved for use in the US, Tyvaso is an inhaled medicine intended to treat pulmonary arterial hypertension.












