Clinical Trials Not Required For <em>Lidoderm</em> Generics, FDA Tells Endo

Clinical Trials Not Required For Lidoderm Generics, FDA Tells Endo

03 Sep 2012

The agency distinguishes the lidocaine pain patch from topical dermatological drugs intended to treat skin diseases in rejecting Endo’s call that ANDA sponsors demonstrate bioequivalence through clinical trials, rather than merely pharmacokinetic studies.

Clinical trials are not required to demonstrate bioequivalence of generic lidocaine patches to Endo Pharmaceuticals Inc.’s reference drug Lidoderm, FDA said.

In an Aug. 22 citizen’s petition response that paved the way for approval of ANDA first-filer Allergan PLC’s lidocaine...