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Re: mouton29 post# 111616

Tuesday, 12/28/2010 2:19:02 PM

Tuesday, December 28, 2010 2:19:02 PM

Post# of 257257
Biomaven,

""On November 2, 2007, the FDA acknowledged, in a letter to Amphastar from the Office of Generic Drugs, that Amphastar had met the FDA’s five “sameness” criteria and therefore had demonstrated its enoxaparin’s sameness with Lovenox® in its ANDA.""

Mouton,

""I checked the docket for the case and don't see an exhibit of said letter.""

Dew,

...If true, why is Amphastar proceding like this?

tia

y3

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