Written on: December 5, 2025 by SprayTM
Amneal Pharmaceuticals, Inc. has received approval from the U.S. Food & Drug Administration (FDA) for its albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR HFA (albuterol sulfate inhalation aerosol), a registered trademark of Teva Respiratory LLC.
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults and children 12 years of age and older with reversible obstructive airway disease.
This approval follows the company’s recent FDA approval of its beclomethasone dipropionate inhalation aerosol, a generic equivalent of QVAR (beclomethasone dipropionate inhalation aerosol). (Read about that here.)
“Securing two significant inhalation approvals this quarter—first beclomethasone dipropionate and now albuterol—highlights the tremendous progress our teams have made in a highly complex respiratory category,” said Srinivas Kone, Senior VP, Chief Scientific Officer–Affordable Medicines.
“These achievements are the result of years of hard work, engineering excellence and investment in our respiratory platform, and they position Amneal to deliver meaningful growth and patient impact.”
PROAIR HFA and QVAR are registered trademarks of Teva Respiratory LLC.
