EAST WINDSOR, N.J. — Aurobindo Pharma Ltd. has gained final approval from the Food and Drug Administration for levalbuterol inhalation solution in dosages of 0.31 mg/3 ml, 0.63 mg/3 ml and 1.25 mg/3 ml.

The medication is used to treat breathing problems in patients with conditions such as asthma or chronic obstructive pulmonary disease (COPD). Aurobindo said its levalbuterol inhalation product is a generic version of Xopenex from Oak Pharmaceuticals Inc.

A short-acting bronchodilator, levalbuterol inhalation solution relaxes muscles in the airways to facilitate air flow to the lungs. The drug is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children ages 6 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*.

U.S. sales of levalbuterol inhalation solution (0.31 mg/3 ml, 0.63 mg/3 ml and 1.25 mg/3 ml) totaled $130 million for the 12 months ended in November 2016, according to IMS Health data reported by Aurobindo.