FDA Approves ANDA for Albuterol Sulfate

FDA announced in a June 4, 2021 release that it had approved an abbreviated new drug application submitted by Sandoz for albuterol sulfate inhalation aerosol 90 mcg (base)/actuation in a metered dose inhaler on June 1. The drug is used for the treatment or prevention of bronchospasm (i.e., narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease, such as asthma, and for the prevention of exercise-induced bronchospasm in patients four years of age and older.

In the release, the agency said, “The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency and has prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with COVID-19. We remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.”

Sandoz had previously announced in a March 16, 2021 press release that it had in-licensed commercial distribution rights to the brand and authorized generic of respiratory inhalation medicine Proventil HFA (albuterol sulfate) Inhalation Aerosol from Kindeva Drug Delivery, which is a global contract development and manufacturing organization, for patients in the United States. Both the brand and generic drug of Proventil are manufactured in California.

Sandoz noted in the March press release that there has been a surge in demand for albuterol medicines over the past year from both hospitals and pharmacies in the US.

Source: FDA, Sandoz