Mylan announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Sildenafil Citrate Tablets, the generic of Pfizer‘s Revatio.
Revatio is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Revatio is a phosphodiesterase type 5 inhibitor that increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.
Sildenafil Citrate is available in 20mg dosage strengths tablets and Mylan has already begun shipping this product.
For more information call (800) RX-MYLAN or visit www.mylan.com.