New Drug Approvals: May 2008

May 1	FDA Approves Advair 250/50 for Reduction of Exacerbations in Patients With COPD

May 7	Trudell Aerocount Innovation to Benefit U.S. Asthma Patients

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 12	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 21	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)

May 27	ZymoGenetics Announces FDA Approval of Recothrom 20,000-IU Vial Size and Co-Packaging with Spray Kit

May 27	Osmotica Pharmaceutical Receives FDA Approval to Market Novel Forms of Extended Release Venlafaxine HCl

May 28	New Eloxatin (oxaliplatin injection) Prescribing Information in the U.S. Includes Six-Year Overall Survival Data

May 30	First Taxane-Based Non-Anthracycline Containing Chemotherapy in Combination With Herceptin (TCH) for HER2 Positive Early Breast Cancer Patients Obtains Approval From the FDA

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New Drug Approvals: May 2008

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