FDA Revokes Final ANDA Approval, Determining That a Preliminary Injunction Extends the 30 Month Stay

On Friday, September 17, 2010, the FDA issued a decision revoking final approval for Tevas ANDA for a generic version of Aricept® (donepezil hydrochloride), Eisais billion-dollar-a-year medication for the treatment of Alzheimers disease. In a matter of first impression, the FDA concluded that it had issued final approval of Tevas donepezil ANDA in error because a preliminary injunction awarded to Eisai prior to the expiration of the 30-month stay triggered an extension of the stay of approval until a court decision on the merits of the litigation. To the extent a case schedule cannot result in a final decision before the expiration of the 30-month stay, the FDAs ruling reinforces the importance of seeking preliminary injunctive relief in sufficient time to allow a court to decide the motion before the expiration of that stay.

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