New Drug Approvals Archive - November 2007

Abilify (aripiprazole)

Patient Population Altered: October 29, 2007

• U.S. Food and Drug Administration Approves Abilify (aripiprazole) for Adolescent Patients With Schizophrenia

Crestor (rosuvastatin calcium)

New Indication Approved: November 8, 2007

• Crestor Now Indicated to Slow the Progression of Atherosclerosis in Patients With Elevated Cholesterol

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 withMonthly Maintenance Dosing
• Mircera (epoetin beta-methoxy polyethylene glycol) FDA Approval History

Seroquel XR (quetiapine)

New Indication Approved: November 15, 2007

• Seroquel XR Receives Approval From FDA for Maintenance Treatment ofSchizophrenia
• Seroquel XR (quetiapine) FDA Approval History

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)

Cymbalta (duloxetine)

New Indication Approved: November 28, 2007

• FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder
• Cymbalta (duloxetine) FDA Approval History

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
• Triesence (triamcinolone acetonide) FDA Approval History

Mircera (epoetin beta-methoxy polyethylene glycol)

Patient Population Altered: June 7, 2018

• FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
• Mircera (epoetin beta-methoxy polyethylene glycol) FDA Approval History