New Drug Approvals Archive - February 2008

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
• Asmanex (mometasone furoate) FDA Approval History

Simcor (niacin ER and simvastatin) Tablets

Date of Approval: February 15, 2008
Company: Abbott
Treatment for: Hyperlipidemia

Simcor (niacin extended-release/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
• Simcor (niacin ER and simvastatin) FDA Approval History

Xyzal (levocetirizine dihydrochloride)

New Dosage Form Approved: January 28, 2008

• FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solutionfor the Relief of Seasonal and Year Round Allergies and ChronicIdiopathic Urticaria
• Xyzal (levocetirizine dihydrochloride) FDA Approval History

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
• Xyntha (antihemophilic factor (recombinant), plasma/albumin free ) FDA Approval History

Humira (adalimumab)

New Indication Approved: February 21, 2008

• Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis

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
• Avastin (bevacizumab) FDA Approval History

Nexium (esomeprazole)

New Dosage Form Approved: February 27, 2008

• FDA Approves Nexium for Use in Children Ages 1-11 Years

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)
• Arcalyst (rilonacept) FDA Approval History

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 WithBipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

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 MajorDepressive Disorder
• Pristiq (desvenlafaxine) FDA Approval History

Simcor (niacin ER and simvastatin)

New Dosage Form Approved: July 28, 2010

• Abbott's Simcor (niacin extended-release/simvastatin) Receives FDA Approval for New Dosage Strengths
• Simcor (niacin ER and simvastatin) FDA Approval History