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Orathecin Approval Status

  • FDA approved: No
  • Brand name: Orathecin
  • Generic name: rubitecan
  • Dosage form: Capsules
  • Company: SuperGen Inc.
  • Treatment for: Pancreatic Cancer

Development Status and FDA Approval Process for Orathecin

DateArticle
Jan  3, 2005SuperGen Announces Withdrawal of Orathecin NDA
Nov 29, 2004SuperGen Announces 90 Day Extension of FDA Review Date for Orathecin New Drug Application
Mar 26, 2004SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing
Mar 26, 2004SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing
Jan 28, 2004SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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