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Re: mouton29 post# 9189

Saturday, 06/23/2012 3:33:50 PM

Saturday, June 23, 2012 3:33:50 PM

Post# of 20689

What you say makes sense, else how would generics be launched at-risk?

That’s correct—“at risk” generic launches (which are more common than some people realize,) require final rather than tentative FDA approval.

On the other hand, TEVA’s press release says they believe the [Distrcit Court] ruling "should" prevent FDA approval…

Teva’s PR uses the word should rather than the word will because Teva is stating an opinion rather than a matter of Hatch-Waxman law.

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