New Drug Approvals Archive
New Drug Approvals: November 2008
| November 3 | Treanda (bendamustine hydrochloride)
New Indication Approved: October 31, 2008 Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma |
| November 6 | Crestor (rosuvastatin calcium)
New Indication Approved: November 6, 2008 Crestor Approved for Primary Dysbetalipoproteinemia |
| November 6 | Ranexa (ranolazine)
New Indication Approved: November 5, 2008 FDA Approves Ranexa for First Line Anti Anginal Use |
| November 11 | Cardene (nicardipine)
New Formulation Approved: November 7, 2008 EKR Therapeutics Broadens Its Ready-to-Use Cardene I.V. Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags |
| November 12 | Focalin XR (dexmethylphenidate)
Labeling Revision Approved: October 17, 2008 Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD) FDA Approves 30-Minute Onset of Action for Focalin XR |
| November 13 | Premarin Vaginal Cream (conjugated estrogens)
New Indication Approved: November 7, 2008 FDA Approves Low-dose Regimen of Premarin Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse |
| November 14 | Banzel (rufinamide) Tablets 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 |
| November 20 | Promacta (eltrombopag) Tablets Date of Approval: November 20, 2008 Company: GlaxoSmithKline Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura. FDA Approves Promacta (eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder |
| November 20 | Nucynta (tapentadol) Immediate Release 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 |
| November 28 | SCE-A (Synthetic Conjugated Estrogens-A) Vaginal Cream - formerly Bijuva Date of Approval: November 28, 2008 Company: Duramed Pharmaceuticals, Inc. Treatment for: Postmenopausal Symptoms 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 |
New Drug Approvals Archive
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