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Tarceva FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 7, 2023.

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

Tarceva (erlotinib) is a kinase inhibitor for the treatment of certain types of non-small cell lung cancer, and pancreatic cancer.

Development timeline for Tarceva

DateArticle
May 15, 2013Approval FDA Approves Tarceva (Erlotinib) Tablets and Cobas EGFR Mutation Test for Specific Type of Lung Cancer
Apr 18, 2010Approval FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer
Nov  2, 2005Approval FDA Approves Tarceva in Combination with Gemcitabine Chemotherapy for Treatment of Locally Advanced, Inoperable or Metastatic Pancreatic 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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