FDA Approved Mylan for Generic Boniva ANDA

Mylan Inc. (Nasdaq: MYL) introduced that its subsidiary Mylan Pharmaceuticals Inc. receives final consent that came from the U.S. Food and Drug Administration because of its Shortened to New Drug Application (ANDA) for Ibandronate Sodium Tablets, 150mg. This supplement would be the generic edition of Roche's Boniva, and that is indicated for treatment and protection against osteoporosis in postmenopausal females.

Boniva had U.S. sales of about $517 million for 12 months ending Dec. 31, 2011, in accordance with IMS Health. Mylan is shipping this product straightaway.

At present, Mylan has 173 ANDAs imminent FDA approval symbolizing $100.9 billion in yearly sales, in accordance with IMS Health. Forty-two of those pending ANDAs are possible first-to-file chances, symbolizing $27.4 billion in yearly brand sales, for the 12 months ending December 31, 2011, in accordance with IMS Health.