Aurobindo Receives FDA Approval for Levalbuterol Inhalation Solution 0.31 mg/3 ml; 0.63 mg/3 ml; 1.25 mg/3 ml

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Levalbuterol Inhalation Solution 0.31 mg/3 ml, 0.63 mg/3 ml, and 1.25 mg/3 ml. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Levalbuterol Inhalation Solution 0.31 mg/3 ml; 0.63 mg/3 ml; 1.25 mg/3 ml to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Xopenex® by Oak Pharmaceuticals Inc.

Levalbuterol Inhalation Solution 0.31 mg/3 ml; 0.63 mg/3 ml; 1.25 mg/3 ml is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

The product has an estimated market size of $130M for the twelve months ending November 2016 according to IMS*.
Levalbuterol Inhalation Solution 0.31 mg/3 ml; 0.63 mg/3 ml; 1.25 mg/3 ml represents the latest addition to Aurobindo’s broad product portfolio.
* IMS National Sales Perspectives: Retail and Non-Retail MAT November 2016