Mylan announced that it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Levalbuterol Inhalation Solution, the generic version of Sunovion’s Xopenex inhalation solution.
Xopenex is a beta-2 agonist indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children >6 years of age with reversible obstructive airway disease.
Levalbuterol Inhalation Solution is available in 0.31mg/3mL (0.0103%), 0.63mg/3mL (0.021%), and 1.25mg/3mL (0.042%) strengths. Mylan has begun shipping this product.
For more information call (888) RX-MYLAN or visit www.mylan.com.