Mylan Inc. subsidiary Mylan Specialty L.P. has received approval from the Food and Drug Administration for levalbuterol inhalation solution.


Mylan, Mylan Specialty, levalbuterol inhalation solution, Xopenex generic, Sunovion, brochospasm, bronchodilator, reversible obstructive airway disease


































































































































































































































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Mylan releases Xopenex generic

March 18th, 2013

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.

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