The US FDA has approved the first generic Proventil HFA (albuterol sulfate) metered dose inhaler (90 mcg).
The generic albuterol sulfate, which is manufactured by Cipla Ltd, is approved to treat/prevent bronchospasm in patients four-and-older who have reversible obstructive airway disease such as asthma or COPD. It is also approved to prevent exercise-induced bronchospasm in this age group.
This is the second generic albuterol sulfate approved in recent months by the FDA, which greenlit a ProAir HFA generic made by Perrigo Pharma on Feb 24. The agency noted a spike in albuterol use during the COVID-19 outbreak in the approval.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” FDA Commissioner Stephen M. Hahn, MD said in a statement. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”
The most common side effects associated with albuterol sulfate MDI (90 mcg/Inhalation) are upper respiratory tract infection, rhinitis, nausea, vomiting, tachycardia, tremor and nervousness, according to the FDA.