New Drug Approvals Archive - November 2008

Banzel (rufinamide)

Date of Approval: November 14, 2008
Company: Eisai Medical Research Inc.
Treatment for: Lennox-Gastaut Syndrome

Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

• FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder
• Banzel (rufinamide) FDA Approval History

Promacta (eltrombopag) Tablets

Date of Approval: November 20, 2008
Company: Novartis Pharmaceuticals Corporation
Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura, Thrombocytopenia, Aplastic Anemia

Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, thrombocytopenia in patients with chronic hepatitis C, and patients with severe aplastic anemia.

• FDA Approves Promacta (eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
• Promacta (eltrombopag) FDA Approval History

Nucynta (tapentadol) Tablets

Date of Approval: November 20, 2008
Company: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Treatment for: Pain

Nucynta (tapentadol) is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.

• FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
• Nucynta (tapentadol) FDA Approval History

SCE-A (Synthetic Conjugated Estrogens-A) Vaginal Cream

Date of Approval: November 28, 2008
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Postmenopausal Symptoms

Marketing Status: Discontinued

SCE-A (synthetic conjugated estrogens, A) Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.

• FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream
• SCE-A (Synthetic Conjugated Estrogens-A) FDA Approval History