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Torisel Approval History

  • FDA approved: Yes (First approved May 30th, 2007)
  • Brand name: Torisel
  • Generic name: temsirolimus
  • Dosage form: Injection
  • Company: Wyeth Pharmaceuticals, Inc.
  • Treatment for: Renal Cell Carcinoma

Torisel (temsirolimus), an inhibitor of mTOR kinase, is an antineoplastic agent indicated for the treatment of patients with advanced renal cell carcinoma.

Development History and FDA Approval Process for Torisel

May 31, 2007Approval FDA Approves Torisel, a Targeted First-in-Class mTOR Inhibitor forthe Treatment of Advanced Kidney Cancer
Apr  6, 2007Wyeth Provides Update on FDA Review of the Torisel New Drug Application
Dec 19, 2006FDA Grants Torisel NDA Priority Review Status
Oct  6, 2006Wyeth Submits NDA and MAA for Torisel for the Treatment of Advanced Renal Cell Carcinoma

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