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Office of Oncology Drug Products (OODP)

What's New from OODP

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  • FDA Approves Romiplostim (Nplate) for the Treatment of Thrombocytopenia. More information (August 22)

  • Velcade (bortezomib) is Approved for Initial Treatment of Patients with Multiple Myeloma. More information (June 24)

  • FDA approves bendamustine hydochloride (Treanda) for the treatment of patients with chronic lymphocytic leukemia (CLL). More information (March 20)

  • Bevacizumab (Avastin) was granted accelerated approval for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer. More information (Feb. 22)


  • FDA approves sorafenib (Nexavar) for the treatment of unresectable hepatocellular carcinoma. More information (Nov. 19)

  • FDA grants cccelerated approval of a new dosing regimen of Dasatinib (Sprycel) More information (Nov. 8)

  • FDA approves safety-related product labeling changes for the erythropoiesis-stimulating agents Epogen, Procrit, and Aranesp. (Nov. 8) More information

  • FDA grants accelerated approval to nilotinib (Tasigna) to treat leukemia. More information (Oct. 30)

  • FDA approves ixabepilone for injection (Ixempra) for two indications. More information (Oct. 16)

  • FDA expands labeling for cetuximab (marketed as Erbitux). More information (Oct. 2)

  • FDA approves new uses for docetaxel (Taxotere). More information (Sep. 28)

  • FDA approves new uses for raloxifene hydrochloride (Evista). More information (Sept. 13)

  • Dexrazoxane hydrochloride (Totect) was approved for the treatment of anthracycline extravasation. More information (Sept. 6)

  • Temsirolimus (Torisel) was approved for the treatment of advanced renal cell carcinoma. More information (May 30)

  • Doxorubicin HCl liposome injection (Doxil) was approved for use in combination with bortezomib in patients with multiple myeloma. More information (May 17)

  • A new indication for dalteparin sodium injection (Fragmin) was approved. More information (May 1)

  • Eculizumab injection (Soliris) was approved for the treatment of paroxysmal nocturnal hemoglobinuria. More information (March 16)

  • Lapatinib tablets (Tykerb) was approved for advanced metastatic breast cancer patients. More information (March 13)

  • FDA approved labeling changes for erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp) More information (March 9)

  • FDA was notified of the results from a multicenter, double-blind, randomized, placebo-controlled study of darbepoetin alfa (Aranesp) More information (Feb. 22)

  • FDA converted approval from accelerated to regular for sunitinib malate (Sutent) for the treatment of advanced renal cell carcinoma. More information (Feb. 2)

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Created: July 20, 2006;
Updated: August 25, 2008
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