New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

January 2006

January 9

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 (immune globulin subcutaneous (human)) FDA Approval History

January 9

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.

Taclonex (calcipotriene and betamethasone dipropionate) FDA Approval History

January 26

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 (sunitinib malate) FDA Approval History

January 27

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 (ranolazine) FDA Approval History

January 27

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 (insulin inhalation) FDA Approval History

January 30

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 (hepatitis B immune globulin) FDA Approval History

January 31

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 (lubiprostone) FDA Approval History

August 14

Ranexa (ranolazine)

New Formulation Approved: August 14, 2007

Ranexa (ranolazine) FDA Approval History

December 19

Ranexa (ranolazine)

New Dosage Regimen: December 17, 2007

Ranexa (ranolazine) FDA Approval History

May 12

Taclonex (calcipotriene and betamethasone dipropionate)

New Dosage Form Approved: May 9, 2008

Taclonex (calcipotriene and betamethasone dipropionate) FDA Approval History

November 6

Ranexa (ranolazine)

New Indication Approved: November 5, 2008

Ranexa (ranolazine) FDA Approval History

May 20

Sutent (sunitinib malate)

New Indication Approved: May 20, 2011

Sutent (sunitinib malate) FDA Approval History

April 23

Amitiza (lubiprostone)

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

Amitiza (lubiprostone) FDA Approval History

Hide
(web2)