Ranbaxy's ANDAs for Diflucan may not be approved until Pfizer's pediatric exclusivity expires in July, a federal appeals court ruled.

Final ANDA approval "did not automatically occur upon the dismissal of the underlying patent litigation, the expiration of the patent, and the termination of the 30-month statutory stay," the D.C. Circuit Court of Appeals April 26 ruling states.

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 Also see "Ranbaxy Diflucan Generic Launch Delayed Until July Under Court Ruling" - Pink Sheet, 11 March, 2004.).

- Sue Sutter

Ranbaxy Diflucan Generic Delayed Until July, Court Affirms

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