CANONSBURG (dpa-AFX) - Mylan Inc. (MYL) Monday said received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Levalbuterol Inhalation Solution.
The 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 had US sales of about $438.8 million for the 12 months ending December 31, 2012, according to IMS Health. Mylan has begun shipping this product.
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