Rubitecan

Drugbox
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CAS_number = 91421-42-0
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PubChem = 11954380
DrugBank =
C = 20 |H = 15 |N = 3 |O = 6
molecular_weight = 393.349 g/mol
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routes_of_administration = Oral

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, [cite web |url=http://www.drugs.com/nda/orathecin_040128.html |title=Drugs.com, SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer |accessdate=2008-03-25 |format= |work= ] and was accepted for filing on March 2004. [cite web |url=http://www.drugs.com/nda/orathecin_040326.html |title=Drugs.com, SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing |accessdate=2008-03-25 |format= |work= ]

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, [cite web |url=http://www.drugs.com/nda/orathecin_050103.html |title=Drugs.com, SuperGen Announces Withdrawal of Orathecin NDA |accessdate=2008-03-25 |format= |work= ] and on January 2006, the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) was also withdrawn. [cite web |url=http://www.emea.europa.eu/humandocs/PDFs/EPAR/orathecin/2621906en.pdf |title=Press release from the EMEA website regarding withdrawal of Orathecin MAA |accessdate=2008-03-25 |format=PDF |work= ]

References