Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Bromfenac Ophthalmic Solution, 0.09% (Twice Daily Administration), based on a development and supply agreement with Coastal Pharmaceuticals. This product is the first generic version of ISTA's Xibrom Ophthalmic Solution, 0.09% (Twice Daily Administration), a treatment for postoperative inflammation in patients who have undergone cataract extraction.
Bromfenac Ophthalmic Solution had US sales of approximately $116 million for the 12 months ending March 31, 2011, according to IMS Health.
Currently, Mylan has 169 ANDAs pending FDA approval representing $100.7 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending December 31, 2010, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.