New Drug Approvals Archive - 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).

• Vivaglobin Approved - ZLB Behring - Treatment for Primary Immunodeficiencies

Vivaglobin (immune globulin subcutaneous (human)) FDA Approval History

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.

• FDA Approves Taclonex - Once Daily Therapy for Treatment of Psoriasis

Taclonex (calcipotriene and betamethasone dipropionate) FDA Approval History

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 patients with gastrointestinal stromal tumors, advanced kidney cancer and pancreatic neuroendocrine tumors.

• Sutent Approved - Pfizer Inc. - Treatment for Gastrointestinal Stromal Tumors and Renal Carcinoma

Sutent (sunitinib malate) FDA Approval History

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.

• Ranexa Approved - CV Therapeutics, Inc. - Treatment for Chronic Angina

Ranexa (ranolazine) FDA Approval History

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.

• Exubera Approved - Pfizer Inc - Treatment for Type 1 and Type 2 Diabetes in Adults

Exubera (insulin inhalation) FDA Approval History

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.

• HepaGam B - Cangene - Treatment for Exposure to Hepatitis B

HepaGam B (hepatitis B immune globulin) FDA Approval History

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.

• Amitiza - Sucampo Pharmaceuticals, Inc. - Treatment for Constipation

Amitiza (lubiprostone) FDA Approval History

Ranexa (ranolazine)

New Formulation Approved: August 14, 2007

• CV Therapeutics Launches 1000 mg Ranexa Tablet

Ranexa (ranolazine) FDA Approval History

Ranexa (ranolazine)

New Dosage Regimen: December 17, 2007

• FDA Approves New Mechanism of Action Labeling for Ranexa

Ranexa (ranolazine) FDA Approval History

Taclonex (calcipotriene and betamethasone dipropionate)

New Dosage Form Approved: May 9, 2008

• FDA Approves Taclonex Scalp - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis

Taclonex (calcipotriene and betamethasone dipropionate) FDA Approval History

Ranexa (ranolazine)

New Indication Approved: November 5, 2008

• FDA Approves Ranexa for First Line Anti Anginal Use

Ranexa (ranolazine) FDA Approval History

Sutent (sunitinib malate)

New Indication Approved: May 20, 2011

• FDA Approves Sutent for Rare Type of Pancreatic Cancer

Sutent (sunitinib malate) FDA Approval History

Amitiza (lubiprostone)

New Indication Approved: April 19, 2013
Treatment for: Chronic Idiopathic Constipation, Opioid-Induced Constipation, Irritable Bowel Syndrome with Constipation

• FDA Approves Amitiza for Opioid-Induced Constipation

Amitiza (lubiprostone) FDA Approval History