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Untitled Document


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FDA Communications
New Cancer Drug Approvals/FDA Updates
In collaboration with the Food and Drug Administration, ONS provides its members with information about newly approved therapies for patients with cancer via email. When such a communication is issued, ONS will immediately send an email indicating the nature of the communication and provide a link to the full text of the communication. This will include information from the product label to provide relevant clinical information on the indication, contraindications, dosing, and safety. Below is a list of archived communications.
| Date Sent | Manufacturer | Drug |
Additional Information |
| May 30, 2007 |
Wyeth, Inc. |
TORISEL™ |
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| May 17, 2007 |
Alza Corporation |
DOXIL® |
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May 1, 2007 |
Pfizer, Inc. |
Fragmin® |
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| March 16, 2007 |
Alexion Pharmaceuticals, Inc. |
Soliris™ |
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| March 13, 2007 |
GlaxoSmithKline |
Tykerb® |
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| December 08, 2006 |
Millennium Pharmaceuticals, Inc.
|
Velcade® |
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| November 20, 2006 |
Genentech, Inc.
|
Herceptin® |
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| October 23, 2006 |
Novartis Pharmaceuticals |
Gleevec® |
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| October 18, 2006 |
Sanofi-Aventis |
Taxotere® Injection Concentrate |
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| October 11, 2006 |
Genentech, Inc. |
Avastin™ |
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| October 6, 2006 |
Merck & Co., Inc. |
Zolinza™ |
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| October 5, 2006 |
Genentech, Inc. |
Rituxan® |
Two supplemental applications listed |
| September 27, 2006 |
Genentech |
Avastin |
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| September 27, 2006 |
Amgen, Inc. |
Vectibix™ |
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| September 27, 2006 |
Novartis Pharmaceuticals |
Gleevec® |
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| September 14, 2006 |
Wyeth Pharmaceuticals Inc. |
Neumega® (Oprelvekin) |
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| July 24, 2006 |
Enzon Pharmaceuticals, Inc. |
Oncaspar® |
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| July 14, 2006 |
Eli Lilly and Company |
Gemzar® |
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| June 29, 2006 |
Celgene Corporation |
REVLIMID® |
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| June 28, 2006 |
Bristol-Myers Squibb |
SPRYCEL(™) |
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| June 20, 2006 |
Genentech |
Avastin® |
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| June 16, 2006 |
Merck & Co. |
Gardasil® |
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| June 15, 2006 |
GlaxoSmithKline |
Hycamtin® |
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| May 26, 2006 |
Celgene Corporation |
THALOMID® |
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| May 03, 2006 |
MGI Pharma, Inc |
Dacogen® |
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| May 03, 2006 |
several |
Isotretinoin |
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| March 24, 2006 |
Sanofi-Aventis |
Taxotere® (Docetaxel) |
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| March 1, 2006 |
Imclone Systems |
Erbitux® (Cetuximab) |
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| February 10, 2006 |
Genentech and IDEC Pharmaceuticals |
Rituxan® (rituximab) |
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| January 26, 2006 |
Pfizer, Inc. |
SUTENT® capsules (sunitinib malate) |
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| January 3, 2006 |
Celgene Corporation |
Revlimid(™) (lenalidomide) |
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| December 29, 2005 |
Novartis Pharmaceuticals Corporation |
Femara® (letrozole) |
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| December 21, 2005 |
Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. |
Nexavar® (sorafenib) |
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| September 30, 2005 |
Pfizer Pharmaceuticals |
Camptosar/UGT1A1 Molecular Test |
UGT1A1 Package Insert |
| September 16, 2005 |
ImClone Systems |
Erbitux (cetuximab) |
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| August 3, 2005 |
Pfizer Pharmaceuticals |
Camptosar |
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| June 20, 2005 | AstraZeneca Pharmaceuticals | Gefitinib (Iressa(r)) | |
| June 16, 2005 | Hoffman-LaRoche Inc. | Xeloda®Tablets | |
| March 28, 2005 | Millennium Pharmaceuticals, Inc. | Velcade® | |
| March 16, 2005 | Schering Corporation | Temodar® | |
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