The central factual issue for the hearing, possibly one of the first of its kind, on CDER’s proposal to withdraw Lannett’s methylphenidate ANDA is whether the generic has been shown to be bioequivalent to Janssen Pharmaceuticals’ Concerta.
The central factual issue for the hearing, possibly one of the first of its kind, on CDER’s proposal to withdraw Lannett’s methylphenidate ANDA is whether the generic has been shown to be bioequivalent to Janssen Pharmaceuticals’ Concerta.