New Drug Approvals Archive

New Drug Approvals: February 2008

February 4
Asmanex (mometasone furoate)

Patient Population Altered: February 4, 2008

FDA Approves Asmanex Twisthaler (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11
 
February 15
Simcor (niacin ER and simvastatin) Tablets

Date of Approval: February 15, 2008

Company: Abbott

Treatment for: Hyperlipidemia

Simcor (Niaspan/simvastatin) is a fixed-dose combination lipid therapy used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol.

Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
 
February 19
Xyzal (levocetirizine dihydrochloride)

New Dosage Form Approved: January 28, 2008

FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
 
February 21
Xyntha (antihemophilic factor (recombinant), plasma/albumin free )

Date of Approval: February 21, 2008

Company: Wyeth Pharmaceuticals Inc.

Treatment for: Hemophilia A

Xyntha (Antihemophilic Factor (Recombinant) Plasma/Albumin Free) is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.

FDA Licenses Xyntha, a New Hemophilia Treatment
 
February 22
Humira (adalimumab)

New Indication Approved: February 21, 2008

Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
 
February 25
Avastin (bevacizumab)

New Indication Approved: February 22, 2008

FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer
 
February 28
Nexium (esomeprazole)

New Dosage Form Approved: February 27, 2008

FDA Approves Nexium for Use in Children Ages 1-11 Years
 
February 27
Arcalyst (rilonacept) Injection - formerly Interleukin-1 Trap

Date of Approval: February 27, 2008

Company: Regeneron Pharmaceuticals, Inc.

Treatment for: Cryopyrin-Associated Periodic Syndromes

Arcalyst (rilonacept) is an interleukin-1 inhibitor for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).

FDA Approves Arcalyst - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
 
February 29
Abilify (aripiprazole)

Patient Population Altered: February 27, 2008

U.S. Food and Drug Administration Approves Abilify (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
 
February 29
Pristiq (desvenlafaxine) Extended-Release Tablets

Date of Approval: February 29, 2008

Company: Wyeth Pharmaceuticals

Treatment for: Depression

Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause.

FDA Approves Pristiq for the Treatment of Adult Patients with Major Depressive Disorder
 

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