Amneal Wins FDA Approval For Generic PROAIR® HFA, New FDA Approval Advances Expansion In Complex Inhaled And Respiratory Therapies

Amneal Pharmaceuticals announced that the U.S. FDA has approved its albuterol sulfate inhalation aerosol (90 mcg per actuation), the generic equivalent of PROAIR® HFA. This approval marks another milestone in the company’s expansion into complex respiratory and inhaled therapies, coming shortly after the FDA cleared its generic version of QVAR® (beclomethasone dipropionate inhalation aerosol). Together, the two approvals underscore the company’s progress in developing high-value respiratory products, which are supported by its advanced manufacturing capabilities.

The newly approved albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults and adolescents aged 12 years and older with reversible obstructive airway disease. Common side effects occurring more frequently than with the placebo include headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. The product enters a sizable market, with U.S. annual sales estimated at approximately $1.5 billion, according to IQVIA data for the 12 months ending September 2025.

“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 Dr. Srinivas Kone, Senior Vice President, 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.”

These respiratory approvals reinforce Amneal’s broader strategy of expanding its Affordable Medicines portfolio across complex generics, including inhalation therapies, injectables and biosimilars. The company continues to build a strong pipeline in specialty pharmaceuticals as well, focusing on central nervous system and endocrine disorders.

Headquartered in Bridgewater, NJ, Amneal operates across multiple business segments, including its AvKARE distribution arm, which serves government, institutional, and retail markets. With a portfolio of over 290 products, the company aims to deliver high-quality, accessible medicines while expanding its presence in key therapeutic categories.