The FDA has approved an Aurobindo ANDA for generic albuterol (salbutamol) sulfate inhalation solution and, while the agency did not issue a press release, the news was included in the FDA’s COVID-19 “Daily Roundup” and was promoted by agency social media accounts.
Although the FDA does not currently list albuterol sulfate inhalation solution on its drug shortages list, the announcement said that “The agency recognizes the increased demand for albuterol products during the novel coronavirus pandemic and remains deeply committed to facilitating access to medical products to help address critical needs of the American public.”
On April 9, the American College of Allergy, Asthma and Immunology issued a communication about shortages of albuterol inhalers in some areas of the country due to the COVID-19 outbreak because of a perceived risk that nebulizer use in hospital settings could spread the virus. Health Canada has also issued a notice about shortages of salbutamol inhalers due to COVID-19.
Over the past few months, the FDA has also approved Perrigo’s generic version of ProAir HFA albuterol MDI and Cipla’s generic Proventil HFA albuterol MDI. In its announcement of the approval of Cipla’s ANDA, FDA Commissioner Stephen Hahn also said, “The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic” but did not acknowledge that the increased demand had led to a shortage.
In a tweet, however, Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), stated that “Albuterol has been in very short supply because of the increased use in COVID-19 patients.”
