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PITTSBURGH — Mylan Inc. subsidiary Mylan Specialty L.P. has received approval from the Food and Drug Administration for levalbuterol inhalation solution.
The company said Monday that its levalbuterol product, a generic version of Sunovion’s Xopenex inhalation solution, was cleared for market by the FDA in dosages of 0.31 mg/3 ml (0.0103%), 0.63 mg/3 ml (0.021%), and 1.25 mg/3 ml (0.042%).
Mylan said it has begun shipping the product. A bronchodilator, levalbuterol relaxes muscles in the airways to facilitate air flow to the lungs. The medication is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children age 6 and older with reversible obstructive airway disease.
Levalbuterol inhalation solution (in dosages of 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 cited by Mylan.
