The FDA should not approve generics of Glaxo Smith Kline’s asthma drug Advair Diskus that depend on multiple-batch studies to show pharmacokinetic bioequivalence, according to Mylan.
In a Dec. 5 citizen petition, Mylan, which has submitted its own ANDA referencing the GSK drug, expressed concern about novel bioequivalence methods rival generic manufacturers may be using. Sandoz, another generic applicant, appears to be weighing the use of multiple-batch studies, the petition said.
The FDA should not approve ANDAs unless they include results for bioequivalence studies using the methods laid out in the agency’s guidance on evaluating generic Advair Diskus bioequivalence, Mylan urged. Those methods call for a single-batch trial design.