Mylan Specialty LP, a subsidiary of Mylan Inc. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL (0.0103 per cent), 0.63 mg/3 mL (0.021 per cent), and 1.25 mg/3 mL (0.042 per cent), (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 six 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.
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