Ranbaxy Diflucan generic delayed

Executive Summary

Ranbaxy's ANDAs for Diflucan may not be approved until Pfizer's pediatric exclusivity expires in July, a federal appeals court ruled April 26. Ranbaxy sued FDA in January, seeking approval of its fluconazole ANDAs upon the original Jan. 29 expiration of Pfizer's patent. FDA asserted Ranbaxy's ANDAs could not be approved until Pfizer's six-month pediatric exclusivity extension expires July 29; a federal district court ruled in favor of FDA in March (1"The Pink Sheet" March 15, 2004, p. 29)...