New Drug Approvals Archive

New Drug Approvals: May 2008

May 8	Strattera (atomoxetine) New Indication Approved: May 7, 2008 FDA Approves Strattera for Maintenance of ADHD in Children and Adolescents

May 9	Abilify (aripiprazole) New Indication Approved: May 6, 2008 Abilify (aripiprazole) Receives Expanded Indications for Maintenance Treatment in Both Pediatric Patients (Aged 10-17) With Manic and Mixed Episodes of Bipolar I Disorder and Adolescents (Aged 13-17) With Schizophrenia

May 9	Abilify (aripiprazole) New Indication Approved: May 6, 2008 U.S. Food and Drug Administration Approves Abilify (aripiprazole) for Add-On Treatment to Lithium or Valproate in the Acute Treatment of Adults With Manic and Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features

May 9	OraVerse (phentolamine mesylate) Injection Date of Approval: May 9, 2008 Company: Novalar Pharmaceuticals, Inc. Treatment for: Reversal of Anesthesia OraVerse is a dental anesthetic reversal agent that accelerates the return to normal sensation and function following dental procedures. Novalar Pharmaceuticals, Inc. Receives FDA Approval for OraVerse

May 12	Taclonex (calcipotriene and betamethasone dipropionate) New Dosage Form Approved: May 9, 2008 FDA Approves Taclonex Scalp - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis

May 13	FDA Approves Novo Nordisk's NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors

May 14	Seroquel (quetiapine) New Indication Approved: May 13, 2008 FDA Approves AstraZeneca's Seroquel for Maintenance Treatment in Bipolar Disorder

May 20	Entereg (alvimopan) Capsules Date of Approval: May 20, 2008 Company: Adolor Corporation Treatment for: Postoperative Ileus Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery. Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI)

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