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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