New Drug Approvals: January 2006

Date of Approval: November 21, 2003

Company: Berlex Laboratories

Treatment for Postmenopausal Symptoms

Climara Pro, a thin, translucent patch, is the first once-a-week, combined hormone therapy for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.

Date of Approval: January 6, 2006

Company: Roche/GlaxoSmithKline

Treatment for Osteoporosis

Boniva Injection is an intravenous formulation of the bisphosphonate drug ibandronate sodium, administered quarterly for the treatment of postmenopausal osteoporosis.

Date of Approval: January 9, 2006

Company: ZLB Behring

Treatment for Primary Immunodeficiency Syndrome

Vivaglobin is a pasteurized, polyvalent human normal immunoglobulin for subcutaneous infusion indicated for the treatment of patients with primary immune deficiency (PID).

Date of Approval: January 9, 2006

Company: LEO Pharma

Treatment for Psoriasis

Taclonex is a topical ointment containing a combination of calcipotriene and betamethasone for the treatment of psoriasis vulgaris in adults.

Date of Approval: January 26, 2006

Company: Pfizer Inc.

Treatment for Gastrointestinal Stromal Tumor, Renal Cell Carcinoma

Sutent is an oral multi-kinase inhibitor indicated for the treatment of patients with gastrointestinal stromal tumors and advanced kidney cancer.

Company: ISTA Pharmaceuticals, Inc.

Treatment for Ocular Inflammation Following Cataract Surgery and Ocular Pain Following Cataract Surgery

Date of Approval: January 27, 2006

Company: CV Therapeutics, Inc.

Treatment for Angina Pectoris

Ranexa is a novel antianginal and anti-ischemic agent indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs.

Date of Approval: January 27, 2006

Company: Pfizer Inc.

Treatment for Diabetes Mellitus Type I, Diabetes Mellitus Type II

Exubera is a rapid-acting, dry powder human insulin inhalation indicated for the treatment of adult patients with diabetes mellitus, either as monotherapy, or in combination with oral agents or longer-acting insulins.

Date of Approval: January 30, 2006

Company: Cangene

Treatment for Exposure to Hepatitis B Virus

HepaGam B is hepatitis B immune globulin (human), a purified antibody or hyperimmune that is specific for the hepatitis B virus. HepaGam B is indicated for treatment following acute exposure to hepatitis B virus.

Date of Approval: January 31, 2006

Company: Sucampo Pharmaceuticals, Inc.

Treatment for Constipation -- Chronic, Irritable Bowel Syndrome

Amitiza is a selective chloride channel activator for the treatment of chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in women 18 years and over.