FDA clears United Therapeutics' pulmonary arterial hypertension drug

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The FDA has approved United Therapeutics' Adcirca (tadalafil) tablets for oral administration, with a recommended dose of 40 mg. It is the first once-daily phosphodiesterase type 5 inhibitor for the treatment of pulmonary arterial hypertension.(PAH).

Adcirca is indicated to improve exercise ability in World Health Organization Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease, according to the Silver Spring, Md.-based company.