Mylan receives FDA approval for generic Xalatan Ophthalmic Solution

Apr 4 2011

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 Latanoprost Ophthalmic Solution, 0.005%, the generic version of Pharmacia and Upjohn's Xalatan^® Ophthalmic Solution, an eyedrop that lowers pressure in the eye.  

Mylan President Heather Bresch said: "We are very pleased to introduce this product to the market as it represents Mylan's first ophthalmic solution. 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."  

Latanoprost Ophthalmic Solution had U.S. sales of approximately $711 million for the 12 months ending Dec. 31, 2010, according to IMS Health. Mylan is shipping this product immediately.

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.