FDA approves first generic inhaler to treat bronchospasms

The Food and Drug Administration today approved the first generic albuterol sulfate inhaler to treat and prevent bronchospasms in patients with asthma or reversible obstructive airway disease. “Metered dose inhalers like these are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery,” said FDA Commissioner Stephen Hahn, M.D. “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval. Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices.”