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
Marketing Status: Discontinued
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.
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