Sandoz Asks FDA to Increase Approval Requirements for Generics of GSK’s Advair Diskus

Sandoz is asking the FDA not to approve generic versions of GlaxoSmithKline’s Advair Diskus, unless the copycat versions have undergone adequately controlled pharmacokinetic studies.

In a citizen petition, Sandoz, which is developing an Advair Diskus generic, says the FDA’s recommendations for the development of ANDAs referencing GSK’s product lack “the study design requirements that are necessary to address certain drug-specific characteristics.”

The FDA first issued guidance on bioequivalence recommendations for generics of chronic pulmonary disease treatment in September 2013. Sandoz contends that these guidelines fail to address certain batch-to-batch variability of the product and the blood absorption of the combination product’s active ingredients.