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jbog

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jbog

Re: exwannabe post# 114021

Thursday, 02/03/2011 9:41:38 PM

Thursday, February 03, 2011 9:41:38 PM

Post# of 257262
exwannabe,

From the information that I gathered from Teva's 2004 response to Sanofi's Citizen Petition it seems to me that even if Italfarma didn't change it's IP that Teva's main argument will be around the FDA's rules or latitude of similarity/sameness.

While I hope it wouldn't happen, it is always possible that the FDA will move the goalposts.



http://www.fda.gov/ohrms/DOCKETS/dailys/04/sep04/091504/03P-0064-emc00001-01.pdf
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