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investorgold2002

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investorgold2002

Re: rwwine post# 121927

Monday, 06/20/2011 9:25:51 AM

Monday, June 20, 2011 9:25:51 AM

Post# of 257692
I was referring to the GIVE initiative where presumably certain ANDA applications are given "priority" review

to qualify

1) all patents should have expired or patent cases should be won or no orange book patents listed
2) significant need for that drug/treatment

presumably GIVE priority review would reduce ANDA approval time by half. Fondaparinux ANDA was filed in 2008, it is expected to get approval anytime now

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