Mylan gets final approval from FDA for generic Xopenex Inhalation Solution

Mar 19 2013

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Specialty L.P. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL (0.0103%), 0.63 mg/3 mL (0.021%), and 1.25 mg/3 mL (0.042%), (Concentrate). This product is the generic version of Sunovion's Xopenex^® Inhalation Solution, which is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL, 0.63 mg/3 mL, and 1.25 mg/3 mL, had U.S. sales of approximately $438.8 million for the 12 months ending Dec. 31, 2012, according to IMS Health. Mylan has begun shipping this product.

Currently, Mylan has 182 ANDAs pending FDA approval representing $80 billion in annual sales, according to IMS Health. Thirty-six of these pending ANDAs are potential first-to-file opportunities, representing $21.1 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.