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 Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic 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