New Drug Approvals Archive
New Drug Approvals: January 2005
| January 7 | Abraxane (paclitaxel) for Injectable Suspension Date of Approval: January 7, 2005 Company: American Pharmaceutical Partners, Inc. / American Bioscience, Inc. Treatment for: Breast Cancer Abraxane is an albumin-bound form of paclitaxel indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Abraxane American Pharmaceutical Partners, Inc. / American Bioscience, Inc. - Treatment for Metastatic Breast Cancer |
| January 14 | Menactra (Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Date of Approval: January 14, 2005 Company: Sanofi Pasteur Treatment for: Meningococcal Meningitis Prophylaxis Menactra is the first quadrivalent conjugate vaccine licensed in the U.S. for the prevention of meningococcal disease and is designed to offer protection against four serogroups of Neisseria meningitidis (A, C, Y, W-135), the bacterium that causes meningococcal infection. Menactra Sanofi Pasteur - Treatment for Protection Against Meningococcal Disease |
| January 31 | Eloxatin (oxaliplatin) Injection Date of Approval: January 31, 2005 Company: Sanofi-Synthelabo Treatment for: Colorectal Cancer The aqueous solution formulation of Eloxatin (oxaliplatin injection) is a clear, preservative-free, colorless solution, which does not require reconstitution prior to dilution and administration. Eloxatin, used in combination with infusional 5-FU/LV, is indicated for the treatment of advanced carcinoma of the colon or rectum. Eloxatin Sanofi-Synthelabo - Treatment for Advanced Carcinoma of the Colon or Rectum |
| January 31 | Nascobal (cyanocobalamin) Nasal Spray Date of Approval: January 31, 2005 Company: Nastech Pharmaceutical Company Inc. Treatment for: Vitamin B12 Deficiency Nascobal Nasal Spray is an alternative to Nascobal Nasal Gel, indicated for the treatment of vitamin B12 (cyanocobalamin) deficiency in patients with pernicious anemia, Crohn’s Disease, HIV/AIDS, and multiple sclerosis. Nascobal Nastech Pharmaceutical Company Inc. - Treatment for Vitamin B12 Deficiency |
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