New Drug Approvals Archive

New Drug Approvals: November 2007

November 6
Abilify (aripiprazole)

Patient Population Altered: October 29, 2007

U.S. Food and Drug Administration Approves Abilify (aripiprazole) for Adolescent Patients With Schizophrenia
 
November 9
Crestor (rosuvastatin calcium)

New Indication Approved: November 8, 2007

Crestor Now Indicated to Slow the Progression of Atherosclerosis in Patients With Elevated Cholesterol
 
November 14
Mircera (epoetin beta-methoxy polyethylene glycol) Injection

Date of Approval: November 14, 2007

Company: Roche

Treatment for: Anemia Associated with Chronic Renal Failure

Mircera (epoetin beta-methoxy polyethylene glycol) is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic renal failure.

FDA Approves Mircera: First Renal Anemia Treatment in the US with Monthly Maintenance Dosing
 
November 16
Seroquel (quetiapine)

New Indication Approved: November 15, 2007

Seroquel XR Receives Approval From FDA for Maintenance Treatment of Schizophrenia
 
November 20
Abilify (aripiprazole)

New Indication Approved: November 16, 2007

U.S. Food and Drug Administration Approves Abilify (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)
 
November 30
Cymbalta (duloxetine)

New Indication Approved: November 28, 2007

FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder
 
November 29
Triesence (triamcinolone acetonide) Injectable Suspension

Date of Approval: November 29, 2007

Company: Alcon, Inc.

Treatment for: Temporal Arteritis, Uveitis

Triesence (triamcinolone acetonide) is a synthetic corticosteroid indicated for visualization during vitrectomy and treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

Alcon Receives FDA Approval of Triesence Injectable Triamcinolone Suspension for Use in Eye Surgery
 

New Drug Approvals Archive

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