Posted by Michael Wonder on 08 Apr 2020
FDA approves first generic of a commonly used albuterol/salbutamol inhaler to treat and prevent bronchospasm
8 April 2020 - The U.S. FDA today approved the first generic of Proventil HFA (albuterol sulphate/salbutamol sulphate) metered dose inhaler, 90 mcg/dose inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.
The FDA requires applicants to submit appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency’s rigorous approval standards. These standards ensure quality generic drug products are as safe and effective as their brand name counterparts.
The FDA granted approval of this generic albuterol sulphate inhalation aerosol to Cipla.
