New Drug Approvals Archive - January 2006

January 2006

Vivaglobin (immune globulin subcutaneous (human))

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).

Taclonex (calcipotriene and betamethasone dipropionate) Ointment

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.

Sutent (sunitinib malate) Capsules

Date of Approval: January 26, 2006
Company: Pfizer Inc.
Treatment for: Gastrointestinal Stromal Tumor, Renal Cell Carcinoma, Pancreatic Cancer

Sutent (sunitinib malate) is an oral multi-kinase inhibitor indicated for the treatment of gastrointestinal stromal tumors, advanced renal cell carcinoma (RCC), adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy, and the treatment of pancreatic neuroendocrine tumors.

Ranexa (ranolazine) Extended-Release Tablets

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.

Exubera (insulin inhalation) Powder

Date of Approval: January 27, 2006
Company: Pfizer Inc.
Treatment for: Diabetes Type 1, Diabetes Type 2

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.

HepaGam B (hepatitis B immune globulin)

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.

Amitiza (lubiprostone) Capsules

Date of Approval: January 31, 2006
Company: Sucampo Pharmaceuticals, Inc.
Treatment for: Chronic Idiopathic Constipation, Opioid-Induced Constipation, Irritable Bowel Syndrome with Constipation

Amitiza (lubiprostone) is a selective chloride channel activator for the treatment of chronic idiopathic constipation and opioid-induced constipation in adults, and irritable bowel syndrome with constipation in adult women.