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news.The US Food and Drug Administration (FDA) has approved Mylan Specialty's abbreviated new drug application for the generic equivalent to Sunovion's Xopenex inhalation solution, Levalbuterol inhalation solution USP, 0.31mg/3mL (0.0103%), 0.63mg/3mL (0.021%), and 1.25mg/3mL (0.042%), (Concentrate).
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The Xopenex Inhalation Solution is specified to treat or prevent bronchospasm in patients aged six years and more with reversible obstructive airway disease.
Mylan has begun the shipment of the product.
As per IMS Health data, the sales of Levalbuterol Inhalation Solution USP, 0.31mg/3mL, 0.63mg/3mL, and 1.25mg/3mL were approximately $438.8m for the year ended 31 December 2012 in the US.