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Re: drbio45 post# 102119

Sunday, 08/22/2010 10:46:54 AM

Sunday, August 22, 2010 10:46:54 AM

Post# of 257268

wouldn't this mean that if Teva's [Lovenox] product does not show immunogenicity it will be approved because if there is no immunogenicity it de facto proves purity?

To get FDA approval, Teva has to show sameness according to the FDA’s five-point requirement shown in the table in #msg-52582225.

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