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Alchemia Limited
Abbreviated New Drug Application for Fondaparinux Accepted by US Food and Drug Administration
May 29th, 2009
Australian drug developer, Alchemia Limited (ASX:ACL), 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...
Source: Health Business Week (2009-05-29)
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