FDA approves first generic of albuterol sulfate

FDA on Monday approved the first generic of albuterol sulfate (ProAir HFA) inhalation aerosol. The approval, awarded to Perrigo Pharmaceutical Co., is for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients aged 4...

FDA on Monday approved the first generic of albuterol sulfate (ProAir HFA) inhalation aerosol. The approval, awarded to Perrigo Pharmaceutical Co., is for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients aged 4 years and older. "Today's approval of the first generic drug product for one of the most commonly used rescue inhalers in the U.S. is part of our longstanding commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market," said FDA Commissioner Stephen M. Hahn, MD. "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." The most frequent adverse effects associated with albuterol sulfate inhalation aerosol are headache, rapid heart rate, pain, dizziness, sore throat, rhinitis, chest pain, palpitations, tremor, and nervousness.