New Drug Approvals Archive

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

Date of Approval: January 27, 2006

Company: CV Therapeutics, Inc.

Treatment for: Angina Pectoris

Ranexa (ranolazine) is an antianginal and anti-ischemic agent indicated for the treatment of chronic angina.

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 (lubiprostone) 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.

New Formulation Approved: August 14, 2007

New Dosage Regimen: December 17, 2007

New Dosage Form Approved: May 9, 2008

New Indication Approved: November 5, 2008