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DewDiligence

10/28/10 2:58 PM

#107424 RE: genisi #107420

…I don't believe [Teva] would have submitted an ANDA [if] the drug had been found to be so different from the branded.

What did Teva have to lose by trying? Whatever up-front money Teva paid to ItalFarmaco in 2002 or 2003 was probably de minimis for a company of Teva’s size.
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jq1234

10/28/10 3:07 PM

#107428 RE: genisi #107420

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.



Why? Because it is Teva?

GENZ insisted their 2000L version of Myozyme was the same for more than two years, but finally admitted it was not the same, abondoned the application, then applied 4000L version of the drug, got approved as new drug Lumizyme.

These two situations are not the same. But it illustrates a point that you can't just listen to what a reputable company says. You have to draw inference from regulatory action and other sources.