Mylan gets FDA OK for generic version of Xalatan ophthalmic solution

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The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland
The headquarters of the U.S. Food and Drug Administration is seen in Silver Spring, Maryland.

Mylan Inc. (Nasdaq: MYL) said it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Latanoprost Ophthalmic Solution, an eyedrop that lowers pressure in the eye.

Mylan's Latanoprost Ophthalmic Solution, 0.005 percent, is the generic version of Pharmacia and Upjohn's Xalatan Ophthalmic Solution.

Latanoprost Ophthalmic Solution had sales of about $711 million in the U.S. for the 12 months ending Dec. 31, 2010, according to IMS Health.

Mylan said it is shipping this product immediately.

We are very pleased to introduce this product to the market as it represents Mylan's first ophthalmic solution, Mylan President Heather Bresch said. This signifies a new internal development capability for the company, and we currently have in development a number of additional products in this important category.

Currently, Mylan has 168 ANDAs pending FDA approval representing $98.7 billion in annual sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $25.9 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.

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