The US Food and Drug Administration (FDA) has approved Mylan Laboratories' Abbreviated New Drug Application (ANDA) for sildenafil citrate tablets, 20 mg. This product is the generic version of Pfizer's Revatio, which is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and delay clinical worsening.

Revatio tablets, 20 mg, had US sales of approximately $338.7 million for the 12 months ending September 30, 2012, according to IMS Health. Mylan has begun shipping this product.

Currently, Mylan has 172 ANDAs pending FDA approval representing $79.5 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.