The FDA has announced its approval of a Cipla albuterol sulfate MDI, a generic of 3M’s Proventil HFA for the treatment of asthma. The FDA announcement noted that the agency recently issued a revised draft guidance for generic albuterol sulfate MDIs for products referencing Proventil HFA, as well as ProAir HFA and Ventolin HFA. Earlier this year, the FDA approved Perrigo’s generic version of Teva’s ProAir HFA albuterol MDI.
In April 2019, Par Pharmaceuticals announced that it had reached an agreement with Merck, which markets Proventil HFA, for the launch of an authorized generic of Proventil HFA. 3M Drug Delivery Systems later confirmed that it was manufacturing the authorized generic.
FDA Commissioner Stephen M. Hahn commented, “The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic. We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”
The announcement also touted the agency’s assistance to companies that develop complex generics, saying “The FDA regularly takes steps to help guide industry through the development process for generic products, including complex combination products, such as metered dose inhalers, that consist of a drug and a device. The development of many generic combination products can be more challenging than solid oral dosage forms, like tablets.”
Read the FDA press release.
