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Alchemia new drug application accepted for Fondaparinux
10:41, Monday, 11 May 2009

Sydney - Monday - May 11: (RWE Aust Business News) - Alchemia
(ASX:ACL) partner, Dr Reddy's Laboratories, 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.
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.