| Revision as of 12:10, 17 April 2009 editTXiKiBoT (talk | contribs)567,654 editsm robot Adding: nl:Rubitecan← Previous edit | Revision as of 14:10, 19 August 2009 edit undoAnypodetos (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers, Rollbackers39,350 edits No ATC codeNext edit → | ||
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| | image = Rubitecan.png | | image = Rubitecan.png | ||
| | CAS_number = 91421-42-0 | | CAS_number = 91421-42-0 | ||
| | ATC_prefix = | | ATC_prefix = none | ||
| | ATC_suffix = | | ATC_suffix = | ||
| | PubChem = 11954380 | | PubChem = 11954380 | ||
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| '''Rubitecan''' (], marketing name Orathecin) is an oral ] inhibitor, developed by Supergen. | '''Rubitecan''' (], marketing name '''Orathecin''') is an oral ] inhibitor, developed by Supergen. | ||
| ==History== | ==History== | ||
Revision as of 14:10, 19 August 2009
Pharmaceutical compound| File:Rubitecan.png | |
| Clinical data | |
|---|---|
| Other names | (19S)-19-ethyl-19-hydroxy-10-nitro-17-oxa-3,13-diazapentacyclohenicosa-1(21),2,4,6,8,10,15(20)-heptaene-14,18-dione |
| Routes of administration | Oral |
| ATC code |
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| Identifiers | |
IUPAC name
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| CAS Number | |
| PubChem CID | |
| CompTox Dashboard (EPA) | |
| Chemical and physical data | |
| Formula | C20H15N3O6 |
| Molar mass | 393.349 g/mol g·mol |
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on January 2006, the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) was also withdrawn.
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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