Mylan Inc. (MYL) today announced that it has launched Ibandronate Sodium Injection, 1 mg (base)/mL, packaged in 3 mg (base)/3 mL pre-filled glass syringes, which is the generic version of Hoffmann-La Roche’s Boniva® Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of osteoporosis in postmenopausal women.
Ibandronate Sodium Injection, 1 mg (base)/mL, packaged in 3 mg (base)/3 mL pre-filled glass syringes had U.S. sales of approximately $18.4 million for the 12 months ending June 30, 2014, according to IMS Health.
Currently, Mylan has 288 ANDAs pending FDA approval representing $110.3 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $27.5 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.