The FDA is touting its June 1, 2021 approval of Sandoz’s ANDA for an albuterol sulfate MDI for the treatment of asthma, saying, “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.”
In March 2021, Sandoz announced that it had acquired distribution rights to Proventil HFA albuterol sulfate MDI and an authorized generic from Kindeva Drug Delivery and said at the time that it had already launched the generic MDI. In that announcement, Sandoz also cited the need for additional albuterol inhalers due to COVID-19 shortages, noting “There has been a surge in demand for albuterol medicines over the past year. Hospitals increasingly switched to using metered-dose albuterol inhalers rather than nebulizers to treat the growing number of COVID-19 patients.”
Read the FDA press release.
