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Xcytrin FDA 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 Timeline for Xcytrin

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

Further information

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