Sep 2 2009
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched levalbuterol inhalation solution USP (Concentrate), 0.25%, (1.25 mg/0.5 mL). Mylan, which has already launched the product, will market this product with 180 days of exclusivity.
This product, which is indicated for the treatment or prevention of bronchospasm in patients over 6 years old with reversible obstructive airway disease, is the first generic version of Sepracor Inc.'s Xopenex(R) Inhalation Solution (Concentrate), 0.25%, to be approved by the U.S. Food and Drug Administration (FDA). According to IMS Health, Xopenex Inhalation Solution (Concentrate), 0.25% had total U.S. sales of approximately $18.3 million for the 12 months ending June 30, 2009.