FDA approves first generic albuterol sulfate metered dose inhaler

The US Food and Drug Administration (FDA) has approved the first generic Proventil HFA (albuterol sulfate) metered dose inhaler, 90mcg/inhalation for the treatment or prevention of bronchospasm in patients four years who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.

Bronchospasms, according to the US National Heart, Lung and Blood Institute, are caused by muscles surrounding the airways swelling and tightening, constricting the airways. Physical activity is known to bring on the symptoms – including wheezing, chest tightness, shortness of breath and coughing – in people with asthma. Asthma can affect all ages, but most often starts in childhood.

“The FDA recognises the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Dr Stephen Hahn. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”

The FDA stated that it is continuing to take steps to help guide the industry through generic product development, particularly for complex combination products like inhalers, which contain both the drug and device and are often more challenging to develop than solid dose formulations like tablets. According to the agency, companies can meet with them for guidance as part of it pre-Abbreviated New Drug Application (ANDA) programme and there are guidance documents detailing the recommended steps to submit applications for generic drug products.

The agency also stated that, with regards to generic albuterol sulfate metered dose inhalers, it released a revised draft product-specific guidance in March. The document provides, among other things, bioequivalence recommendations for proposed generic albuterol sulfate inhalers.

The agency granted approval of the generic albuterol sulfate inhalation aerosol to Cipla Limited.