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.
Heart muscle regeneration genes mapped
Researchers have uncovered insights into how stem cells develop and mature into heart muscle...
The cause of 2022's mpox outbreak revealed
Researchers have discovered that the strain of mpox behind the 2022 outbreak was a weakened form...
New gene therapy treats liver disorder in growing children
Researchers have developed a genome-editing approach that repairs a faulty gene directly at its...
