May 16 2011
Mylan Inc. (Nasdaq: MYL) today 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 U.S. 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 Dec. 31, 2010, according to IMS Health.
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