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Tarceva FDA Approval History

FDA Approved: Yes (First approved November 18, 2004)
Brand name: Tarceva
Generic name: erlotinib
Dosage form: Tablets
Company: OSI/Genentech
Treatment for: Non-Small Cell Lung Cancer, Pancreatic Cancer

Tarceva (erlotinib) is a kinase inhibitor indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) and for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

Development Timeline for Tarceva

Apr 18, 2010Approval FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer
Nov 18, 2004Approval FDA Approves Tarceva (erlotinib) for Non-Small Cell Lung Cancer (NSCLC)
Sep 30, 2004OSI Pharmaceuticals Announces Acceptance of Tarceva New Drug Application for Review by the U.S. Food and Drug Administration
Aug  2, 2004OSI Pharmaceuticals and Genentech Announce Completion of New Drug Application for FDA Approval of Tarceva
Jun 29, 2004OSI Pharmaceuticals Announces That Tarceva Has Been Accepted into the FDA's Pilot 1 Program

Further information

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