FDA Rejects Mylan’s Generic Advair ANDA after Denying Sandoz’s Petition

The FDA issued a complete response letter to Mylan for its generic version of the Advair Diskus asthma inhaler developed by GlaxoSmithKline.

Mylan said it is reviewing the response and plans to provide an update on its application once it has discussed the FDA’s feedback with the agency.

Previously, the FDA denied without comment a petition from Novartis’ generics unit, Sandoz that had asked the agency to refrain from approving generic Advair applications that don’t meet certain study conditions. Sandoz is currently developing its own generic inhaler.

Sandoz submitted its petition last October, requesting the agency not approve any ANDAs that don’t control error rates in bioequivalence testing and account for batch-to-batch variability, or ensure that the pharmacokinetic testing is sensitive enough to product differences.