Rubitecan
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Rubitecan
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| Systematic (IUPAC) name | |
| ? | |
| Identifiers | |
| CAS number | |
| ATC code | ? |
| PubChem | |
| Chemical data | |
| Formula | C20H15N3O6 |
| Mol. mass | 393.349 g/mol |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
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| Legal status | |
| Routes | Oral |
Rubitecan (INN, marketing name Orathecin) is an oral topoisomerase inhibitor, developed by Supergen.
[edit] 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on January 2006, the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) was also withdrawn.[4]
[edit] References
- ^ Drugs.com, SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer. Retrieved on 2008-03-25.
- ^ Drugs.com, SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing. Retrieved on 2008-03-25.
- ^ Drugs.com, SuperGen Announces Withdrawal of Orathecin NDA. Retrieved on 2008-03-25.
- ^ Press release from the EMEA website regarding withdrawal of Orathecin MAA (PDF). Retrieved on 2008-03-25.
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