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Post# of 257692
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Re: rwwine post# 121927

Monday, 06/20/2011 6:58:11 PM

Monday, June 20, 2011 6:58:11 PM

Post# of 257692
"Why do you believe FDA approval of mC is tied to the legal case between TEVA and MNTA? "

GIVE initiative (if they can actually use it..dew thinks it can be used only for simple molecules..i don't necessarily agree with that, since i have heard from other sources that fondaparinux is a pretty complex molecule and there is nobody in this world other than Glaxo that makes this API today) that expedites review of ANDA applications, is ONLY applicable for ANDA's that can launch immediately after approval. So the products should satisfy one of the following:
1. No OB patents listed
2. Patent litigation resolved
3. Patents expired

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