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Re: genisi post# 94805

Tuesday, 04/27/2010 2:11:03 AM

Tuesday, April 27, 2010 2:11:03 AM

Post# of 253518

Upon the April, 2008 expiration of the 30-month Hatch-Waxman stay, the prior FDA tentative approval of [Aricept] ANDAs could then be made a final approval.

Correct, but that 30-month stay pertained to a different patent. Why didn’t the FDA require the ANDA filers to make a Paragraph-IV certification on Eisai’s 4895841 patent?


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