FDA approves Revatio injection

Published: 20-Nov-2009
Regulatory

The US Food and Drug Administration (FDA) has approved the intravenous formulation of Revatio (sildenafil), making Revatio the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.


The US Food and Drug Administration (FDA) has approved the intravenous formulation of Revatio (sildenafil), making Revatio the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

The drug is indicated for the treatment of adult patients with pulmonary arterial hypertension to improve their ability to exercise and to delay clinical worsening. Revatio Injection is for the continued treatment of patients with pulmonary arterial hypertension who are prescribed Revatio Tablets but temporarily unable to take oral medication.

The FDA approved Revatio Tablets in June 2005 and the European Medicines Agency (EMEA) in November 2005.

Revatio Injection will be supplied in a single-use vial. The recommended dose is 10mg administered as an intravenous bolus injection three times a day. Revatio in tablet form is available as a 20mg tablet taken three times a day.

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