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investorgold2002

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investorgold2002

Re: investorgold2002 post# 121391

Thursday, 06/09/2011 8:41:53 PM

Thursday, June 09, 2011 8:41:53 PM

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GIVE initiative

http://www.newsrx.com/newsletters/Medical-Letter-on-the-CDC-and-FDA/2009-05-31/290531200943DC.html

Dr Reddy’s filed the ANDA in March 2009 and this notice of acceptance indicates that the ANDA will now enter a period of formal review. Being the first generic version of fondaparinux, the application has been marked for priority review under FDA’s Generic Initiative for Value and Efficiency (the GIVE initiative).

Why wouldn't Copaxone ANDA qualify for GIVE ?!
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