The Food and Drug Administration (FDA) has approved the first AB-rated generic version of Proventil HFA (albuterol sulfate).
The approval of Albuterol Sulfate Inhalation Aerosol has been granted to Cipla Limited. The product is indicated for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. The generic provides 90mcg of albuterol per actuation like the reference product.
In response to the increased demand for albuterol products during the COVID-19 pandemic, the FDA issued a revised draft product-specific guidance for proposed generic albuterol sulfate metered dose inhalers. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public,” said FDA Commissioner Stephen M. Hahn, MD.
Commenting on availability, Umang Vohra MD and Global CEO, Cipla Limited said: “We are planning shipments in a staggered manner. We are also ensuring that we do our bit by donating the product in this time of need.”
For more information visit fda.gov.