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==History== ==History==
On ], ], Supergen announced that it has completed the submission of an NDA for rubitecan to the US FDA, <ref>{{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= }}</ref> and was accepted for filing on March 2004.<ref>{{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= }}</ref> On January 27, 2004, Supergen announced that it has completed the submission of an NDA for rubitecan to the US FDA, <ref>{{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= }}</ref> and was accepted for filing on March 2004.<ref>{{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= }}</ref>


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,<ref>{{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= }}</ref> and on January 2006, the Marketing Authorization Application (MAA) filed with the ] (EMA) was also withdrawn.<ref>{{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= }}</ref> 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,<ref>{{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= }}</ref> and on January 2006, the Marketing Authorization Application (MAA) filed with the ] (EMA) was also withdrawn.<ref>{{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= }}</ref>

Revision as of 00:02, 1 December 2009

Pharmaceutical compound
Rubitecan
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
  • none
Identifiers
IUPAC name
  • (4S)-4-ethyl-4-hydroxy-11-nitro-1H-pyranoindolizinoquinoline-3,14(4H,12H)-dione
CAS Number
PubChem CID
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC20H15N3O6
Molar mass393.349 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

  1. "Drugs.com, SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer". Retrieved 2008-03-25.
  2. "Drugs.com, SuperGen's New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing". Retrieved 2008-03-25.
  3. "Drugs.com, SuperGen Announces Withdrawal of Orathecin NDA". Retrieved 2008-03-25.
  4. "Press release from the EMEA website regarding withdrawal of Orathecin MAA" (PDF). Retrieved 2008-03-25.
Intracellular chemotherapeutic agents / antineoplastic agents (L01)
SPs/MIs
(M phase)
Block microtubule assembly
Block microtubule disassembly
DNA replication
inhibitor
DNA precursors/
antimetabolites
(S phase)
Folic acid
Purine
Pyrimidine
Deoxyribonucleotide
Topoisomerase inhibitors
(S phase)
I
II
II+Intercalation
Crosslinking of DNA
(CCNS)
Alkylating
Platinum-based
Nonclassical
Intercalation
Photosensitizers/PDT
Other
Enzyme inhibitors
Receptor antagonists
Other/ungrouped


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