New Drug Approvals: January 2005

Date of Approval: January 7, 2005

Company: American Pharmaceutical Partners, Inc. / American Bioscience, Inc.

Treatment for Breast Cancer

Abraxane, consisting of albumin-bound paclitaxel nanoparticles, is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Company: Fleming & Company

Treatment for Thyroid Protection in a Radiation Emergency

Date of Approval: December 31, 1969

Company: Warner Chilcott

Treatment for Menopause

Low-dose Femhrt 0.5 mg/2.5 mcg (half the dose of the currently marketed femhrt 1 mg/5 mcg) is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.

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.

Date of Approval: December 31, 1969

Company: Schwarz Pharma AG

Treatment for Anxiety, Panic Disorder

Niravam is an orally administered formulation of alprazolam which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Niravam is used primarily for short-term relief of mild to moderate anxiety, nervous tension, depression and panic attacks.

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.

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.