Ranbaxy sues FDA over Diflucan generics

Executive Summary

A judge will hear arguments March 4 on Ranbaxy's request for a preliminary injunction requiring FDA to immediately approve its ANDAs for fluconazole tablets and oral suspension. In a Jan. 29 lawsuit against the agency, Ranbaxy says Pfizer's six-month pediatric extension for Diflucan should not delay approval of Ranbaxy's ANDAs. Pfizer's only "Orange Book"-listed patent for the antifungal was due to expire Jan. 29 before FDA awarded a six-month extension. Similar issues regarding the impact of a pediatric exclusivity extension on generics have been raised by Mylan in litigation over Alza's Duragesic (fentanyl) patch (1"The Pink Sheet" Dec. 8, 2003, p. 26)...