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New Drug Approvals Archive - November 2008

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 Treanda (bendamustine hydrochloride) FDA Approval History
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 Ranexa (ranolazine) FDA Approval History
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 FDA Approves 30-Minute Onset of Action for Focalin XR Focalin XR (dexmethylphenidate) FDA Approval History
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) 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
November 20	Promacta (eltrombopag) Tablets Date of Approval: November 20, 2008 Company: Novartis Pharmaceuticals Corporation 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 Promacta (eltrombopag) FDA Approval History
November 20	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
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 SCE-A (Synthetic Conjugated Estrogens-A) FDA Approval History
March 4	Banzel (rufinamide) New Dosage Form Approved: March 3, 2011 FDA Approves Banzel (rufinamide) Oral Suspension, 40 mg/mL Banzel (rufinamide) FDA Approval History
August 26	Nucynta (tapentadol) New Dosage Form Approved: August 25, 2011 Nucynta ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain Nucynta (tapentadol) FDA Approval History
August 29	Nucynta (tapentadol) New Indication Approved: August 28, 2012 FDA Approves Nucynta ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Nucynta (tapentadol) FDA Approval History
November 19	Promacta (eltrombopag) New Indication Approved: November 16, 2012 FDA Approves New Indication for Promacta (eltrombopag) Promacta (eltrombopag) FDA Approval History
August 26	Promacta (eltrombopag) New Indication Approved: August 26, 2014 FDA Approves New Indication for Promacta (eltrombopag) for Severe Aplastic Anemia Promacta (eltrombopag) FDA Approval History
February 16	Banzel (rufinamide) Patient Population Altered: February 12, 2015 Eisai Receives Approval for Antiepileptic Drug Banzel (rufinamide) As Adjunctive Treatment For Pediatric Patients Banzel (rufinamide) FDA Approval History
June 12	Promacta (eltrombopag) Patient Population Altered: June 12, 2015 FDA Approves Promacta for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication Promacta (eltrombopag) FDA Approval History
August 24	Promacta (eltrombopag) Patient Population Altered: August 24, 2015 FDA Extends Use of Promacta (eltrombopag) in Pediatric Patients with Immune Thrombocytopenic Purpura Promacta (eltrombopag) FDA Approval History

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