Aurobindo gets FDA approval for generic Xopenex

SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo’s generic of Xopenex (levalbuterol inhalation solution). The drug is indicated to treat or prevent bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease. 

 

Aurobindo’s generic will be available in formulations of 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL. The drug had a market size of $130 million for the 12 months ended November 2016, according to QuintilesIMS data.