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Satraplatin Approval Status

  • FDA approved: No
  • Generic name: Satraplatin
  • Company: GPC Biotech AG
  • Treatment for: Prostate Cancer

Satraplatin is an investigational platinum-based drug for the second-line treatment of hormone refractory prostate cancer.

In July 2007, GPC Biotech AG announced the withdrawal of the New Drug Application (NDA) for satraplatin.

Development Status and FDA Approval Process for Satraplatin

Jul 30, 2007GPC Biotech Withdraws Satraplatin NDA for Accelerated Approval; Plans to Resubmit With Survival Analysis
Jul 25, 2007Oncologic Drugs Advisory Committee Recommends FDA Wait for Overall Survival Analysis of Satraplatin for Treatment of Hormone-Refractory Prostate Cancer
May 15, 2007Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer
Apr 16, 2007FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status
Feb 16, 2007GPC Biotech Submits NDA for Lead Oncology Drug Candidate Satraplatin
Jul 12, 2006GPC Biotech Submits Non-Clinical Section of Rolling NDA for Satraplatin
Dec 15, 2005GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin

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