Amneal Pharma’s new albuterol sulfate inhalation aerosol presents a generic equal for Teva’s ProAir HFA.
The US FDA authorized Amneal Pharma’s albuterol sulfate inhalation aerosol (90 mcg per actuation), in line with the corporate. The product is the generic equal 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 equal of Qvar (beclomethasone dipropionate inhalation aerosol).
“Securing two vital inhalation approvals this quarter—first beclomethasone dipropionate and now albuterol—highlights the great progress our groups have made in a extremely complicated respiratory class,” mentioned Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Inexpensive Medicines. “These achievements are the results of years of exhausting work, engineering excellence, and funding in our respiratory platform, they usually place Amneal to ship significant progress and affected person impression.”
Albuterol sulfate inhalation aerosol is indicated for the therapy or prevention of bronchospasm in adults and youngsters 12 years of age and older with reversible obstructive airway illness.
The most typical adversarial reactions (≥3.0% and >placebo) are headache, tachycardia, ache, dizziness, pharyngitis, and rhinitis.
For full prescribing info, see package deal insert right here. [PDF]
