New Drug Approvals Archive

New Drug Approvals: November 2007

November 6	U.S. Food and Drug Administration Approves Abilify (aripiprazole) for Adolescent Patients With Schizophrenia

November 8	Merck Announces FDA Approval of Easypod: New Electronic Growth Hormone Injection Device

November 9	Crestor Now Indicated to Slow the Progression of Atherosclerosis in Patients With Elevated Cholesterol

November 9	FDA Approves New Sprycel (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

November 12	FDA Approves Nonprescription Zyrtec-D for Allergies

November 12	Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra (lopinavir/ritonavir) Tablet for Pediatric HIV Patients

November 15	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 XR Receives Approval From FDA for Maintenance Treatment of Schizophrenia

November 16	Wyeth Receives FDA Approval of Protonix for Delayed-Release Oral Suspension

November 19	FDA Approves the Allergy Treatment Zyrtec for Use Without a Prescription

November 19	Nexavar First FDA-Approved Drug Therapy for Liver Cancer

November 20	FDA Approves First Combination Therapy for Initial Use in Patients with Moderate to Severe Hypertension

November 20	U.S. Food and Drug Administration Approves Abilify (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)

November 26	Akorn, Inc. Announces FDA Approval for Unit Dose Preservative Free Tetanus Diphtheria Vaccine

November 29	AstraZeneca Receives Six Months Pediatric Exclusivity Patent Extension for Arimidex (anastrozole) from the FDA

November 30	Cymbalta (duloxetine) Delayed-Release Capsules Date of Approval: August 3, 2004 Company: Eli Lilly and Company Treatment for Depression, Anxiety Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Cymbalta was first approved in August 2004 for the acute treatment of major depressive disorder and has since been approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and for the acute treatment of generalized anxiety disorder. New Indication Approved: November 28, 2007 Treatment for: Maintenance Treatment of Major Depressive Disorder Cymbalta is now also approved for the maintenance treatment of major depressive disorder (MDD) in adults. FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder

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