The FDA on Wednesday said it approved Cipla's filing for the first generic version of Merck & Co.'s Proventil HFA (albuterol sulfate) metered-dose inhaler. The medicine is indicated to treat and prevent bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as to prevent exercise-induced bronchospasm in this age group.
Commissioner Stephen Hahn stated that the agency "recognises the increased demand for albuterol products during the novel coronavirus pandemic." Last month, the FDA issued revised draft guidance for proposed generic albuterol sulfate metered-dose inhalers, including drug products referencing Proventil HFA. Among other things, the draft provides recommendations regarding bioequivalence.
The news comes shortly after Perrigo and partner Catalent obtained US approval for the first generic version of Teva's ProAir HFA (albuterol sulfate) inhalation aerosol, which is also indicated for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm in the same age group.
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