Generic opportunity for Alchemia
Friday, 13 March, 2009
Alchemia’s manufacturing partner Dr Reddy’s Laboratories has filed an abbreviated new drug application with the US FDA for a generic version of fondaparinux, used to prevent blood clots.
Fondaparinux is currently marketed by GlaxoSmithKline under the brand name Atrixa, which came off patent in 2002.
No other company has filed an application for a generic in that time as fondaparinux is a difficult molecule to synthesise, Alchemia said.
It is hoped the FDA will review the application within six months of filing under a priority review system.
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