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 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.

• FDA Approves Sutent for Gastrointestinal Stromal Tumors and Advanced Renal Cell 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

Sutent (sunitinib malate)

New Indication Approved: November 16, 2017

• FDA Approves Sutent (sunitinib malate) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma
• Sutent (sunitinib malate) FDA Approval History