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genisi

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genisi

Re: DewDiligence post# 107414

Thursday, 10/28/2010 2:39:09 PM

Thursday, October 28, 2010 2:39:09 PM

Post# of 252273
Sorry for not being clear, by "low-quality" I referred to characterization quality in terms of the sameness to the branded drug. The topic of my posts indeed is not a new branded drug—it’s an application to the FDA for a generic version of Lovenox and my points there were that I'm pretty sure Teva had characterized the generic drug using all the available techniques and I don't believe they would have submitted an ANDA without doing so or in case the drug had been found to be so different from the branded.
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