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Rubitecan

Rubitecan

Rubitecan (INN, marketing name Orathecin) is an oral topoisomerase inhibitor, developed by Supergen.

History

On January 27, 2004, Supergen announced that it has completed the submission of an NDA for rubitecan to the US FDA, and was accepted for filing on March 2004.

On January 2005, Supergen withdrew the NDA for rubitecan, based on feedback indicating that the current data package would not be sufficient to gain US approval, and on January 2006, the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) was also withdrawn.

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