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).
It’s misleading for Alchemia to say that generic Arxitra has FDA priority review; the GIVE initiative for ANDAs is in no way equivalent to priority reviews for NDAs and BLAs, which have firm PDUFA dates.
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