Skip to Content

Xcytrin Approval Status

  • FDA approved: No
  • Brand name: Xcytrin
  • Generic name: motexafin gadolinium
  • Dosage form: Injection
  • Company: Pharmacyclics, Inc.
  • Treatment for: Lung Cancer Brain Metastases

Xcytrin (motexafin gadolinium) is an inhibitor of thioredoxin reductase and ribonucleotide reductase intended for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases.

Pharmacyclics, Inc. announced the receipt of of a not-approvable letter from the U.S. Food and Drug Administration (FDA) in December 2007.

Development Status and FDA Approval Process for Xcytrin

DateArticle
Dec 26, 2007Pharmacyclics Receives Non-Approvable Letter from the FDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
Apr 23, 2007Pharmacyclics Announces FDA Filing of New Drug Application for Xcytrin Injection to Treat Lung Cancer Brain Metastases
Feb 21, 2007Pharmacyclics Receives Refuse to File Letter for Xcytrin
Dec 22, 2006Pharmacyclics Submits NDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
May  9, 2006Pharmacyclics to Submit New Drug Application for Xcytrin for Treatment of Lung Cancer Patients With Brain Metastases

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.

Hide