FDA Clears Intravenous Formulation for Pulmonary Arterial Hypertension

 

November 23, 2009

November 23, 2009 – The U.S. Food and Drug Administration (FDA) Nov. 20 approved Revatio (sildenafil) Injection, an intravenous formulation of Revatio, for the treatment of adult patients with pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening.

The delay in clinical worsening was demonstrated when Revatio was added to background epoprostenol therapy. The efficacy of Revatio has not been adequately evaluated in patients taking bosentan concurrently. Revatio Injection is for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio tablets, but who are temporarily unable to take oral medication.

Revatio Tablets were approved by the FDA in June 2005 and by the European Medicines Agency (EMEA) in November 2005. The American College of Chest Physicians recommends Revatio for adult pulmonary arterial hypertension patients in functional class II and III in its clinical practice guidelines for the treatment of pulmonary arterial hypertension.

Revatio Injection will be supplied in a single-use vial. The recommended dose of Revatio Injection is 10 mg (corresponding to 12.5 mL) administered as an intravenous bolus injection three times a day. Revatio is also available as a 20 mg tablet taken three times a day.

The drug is manufactured by Pfizer. The company saidthe new approval makes its drug the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

For more information: www.pfizer.com