Saturday, 19 July 2008

Clopidogrel Besylate: Generic launch delayed in Europe

Novartis has announced that the timing of generic Plavix with difrent salt (Clopidogrel Besylate)launch delayed in Europe. Novartis also announced that it's difficult to predict when a generic version of Plavix can be launched in Germany, after the German regulator suspended an approval that it had given earlier because the Sanofi-Aventis has opposed the approval of generic form with diffrent salt.
The launches in other European markets depends on the outcome in Germany, and till Germany regulatory agency reviews its decision its difficult to predict the launch of this blockbuster generic.
Swiss generics maker Schweizerhall had earlier received German approval for clopidogrel Besylate ( Sanofi's aproved form is Clopidogrel bisulfate in May.
Sandoz (generic unit of Novartis ) was set to market generic Plavix in Germany as per their agreement with Schweizerhall.
IPPharmadoc's earlier news on Clopidogrel Besylate approval.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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