New Drug Approvals Archive - May 2008

Strattera (atomoxetine)

New Indication Approved: May 7, 2008

• FDA Approves Strattera for Maintenance of ADHD in Children and Adolescents

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

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

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
• OraVerse (phentolamine mesylate) FDA Approval History

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
• Taclonex (calcipotriene and betamethasone dipropionate) FDA Approval History

• FDA Approves Novo Nordisk's NovoSeven RT (Coagulation Factor VIIa[Recombinant] Room Temperature Stable) for Hemophilia Patients WithInhibitors

Seroquel (quetiapine)

New Indication Approved: May 13, 2008

• FDA Approves AstraZeneca's Seroquel for Maintenance Treatment inBipolar Disorder

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)
• Entereg (alvimopan) FDA Approval History