Mylan receives final FDA approval for generic Boniva ANDA

Mar 20 2012

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ibandronate Sodium Tablets, 150mg. This product is the generic version of Roche's Boniva®, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Boniva® had U.S. sales of approximately $517 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan is shipping the product immediately.

Currently, Mylan has 173 ANDAs pending FDA approval representing $100.9 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $27.4 billion in annual brand sales, for the 12 months ending December 31, 2011, according to IMS Health.