Satraplatin FDA 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 timeline for Satraplatin

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

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