Amneal Pharma’s new albuterol sulfate inhalation aerosol offers a generic equivalent for Teva’s ProAir HFA.
The US FDA approved Amneal Pharma’s albuterol sulfate inhalation aerosol (90 mcg per actuation), according to the company. The product is the generic equivalent of ProAir HFA (albuterol sulfate inhalation aerosol), a registered trademark of Teva Respiratory LLC.
This approval follows an FDA approval for Amneal’s beclomethasone dipropionate inhalation aerosol, a generic equivalent of Qvar (beclomethasone dipropionate inhalation aerosol).
“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.”
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.
The most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis.
For full prescribing information, see package insert here. [PDF]
