FDA Approves Generic Levalbuterol Inhalation Solution
The FDA granted final approval for levalbuterol inhalation solution (Aurobindo Pharma).

The new bronchodilator will be available in solutions of 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL for use in a nebulizer. The Division of Bioequivalence has determined that the product is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Xopenex (Oak Pharmaceuticals).

Levalbuterol inhalation solution 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 $130 million for the 12 months ending in November 2016, according to IMS Health....