Is that the site that only updates on the 3rd/4th of every month? So something that gets approval in the early part of a month wont be post up on the FDA site until the 3rd/4th of the next month anyway.
I think the below will answer the question, Reddy's will let us know:
Brisbane, Australia, 11 May 2009: Australian drug developer, Alchemia Limited (ASX:ACL), today announced that its global manufacturing and U.S. marketing partner Dr Reddy’s Laboratories (NYSE:RDY) has received notice of acceptance of its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (FDA) for Fondaparinux Sodium.
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). First generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review.
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