What's New from the Office of Oncology Drug Products

Office of Oncology Drug Products (OODP)

What's New from OODP

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2007

  • 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)

Previous News Items

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  • OODP Listserv: To receive email notification of new approvals, meetings, presentations, and other information from OODP, follow this link https://list.nih.gov/archives/fda-oncology.html and complete the listserv form.
     
  • RSS (Really Simple Syndication) Feed:  Internet technology that enables easy distribution of news and other Web content. Users can access the material through a news reader or ?aggregator,? which downloads and displays the feeds. Users are able to get automatic updates on news items on new approvals, meetings, and other announcements.    

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Created: July 20, 2006;
Updated: June 5, 2007
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