United Therapeutics Gets FDA Approval For Adcirca

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Published: 26-May-2009

United Therapeutics has announced that FDA has approved its drug Adcirca(tadalafil). Adcirca is an oral administration drug for the treatment of pulmonary arterial hypertension (PAH).

The Phase 3 clinical trial (PHIRST-1) randomized, double-blind, 16-week placebo-controlled of Adcirca for PAH, patients taking Adcirca 40 mg (administered as two 20 mg tablets) once daily, achieved a 33 meter improvement in six-minute walk distance compared to the placebo group. In addition, PHIRST-1 patients taking Adcirca 40mg experienced less clinical worsening compared to the placebo group.

Roger Jeffs, President and Chief Operating Officer at United Therapeutics, said: Our dedicated team at United Therapeutics looks forward to working closely with the PAH community as we prepare to launch ADCIRCA in the United States at the beginning of August this year.

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