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Revision as of 12:10, 17 April 2009
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| Other names | (19S)-19-ethyl-19-hydroxy-10-nitro-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4,6,8,10,15(20)-heptaene-14,18-dione |
| Routes of administration | Oral |
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| Formula | C20H15N3O6 |
| Molar mass | 393.349 g/mol g·mol−1 |
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, [1] and was accepted for filing on March 2004.[2]
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,[3] and on January 2006, the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) was also withdrawn.[4]
References
- ^ "Drugs.com, SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer". Retrieved 2008-03-25.
- ^ "Drugs.com, SuperGen's New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing". Retrieved 2008-03-25.
- ^ "Drugs.com, SuperGen Announces Withdrawal of Orathecin NDA". Retrieved 2008-03-25.
- ^ "Press release from the EMEA website regarding withdrawal of Orathecin MAA" (PDF). Retrieved 2008-03-25.
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