Sanofi-aventis has become aware of the registrations of Clopidogrel besylate in Germany, as reflected in the AMIS-database of the BfArM (The German Federal Drug Regulatory Authority) on May 28, 2008. These registrations refer to a different salt of clopidogrel than the one of Plavix® (clopidogrel bisulfate), and the products are labelled only for a limited number of indications when compared to Plavix®.
IP pharma doc has earlier speculated the same in its earlier post
Friday 30 May, 2008
Clopidogrel: Generic players filed Marketing Authorization Application (MAA) with Besylate salt in Germany
