New Drug Approvals Archive - November 2008

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

Crestor (rosuvastatin calcium)

New Indication Approved: November 6, 2008

• Crestor Approved for Primary Dysbetalipoproteinemia

Ranexa (ranolazine)

New Indication Approved: November 5, 2008

• FDA Approves Ranexa for First Line Anti Anginal Use
• Ranexa (ranolazine) FDA Approval History

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

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

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

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

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

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 - 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

Banzel (rufinamide)

New Dosage Form Approved: March 3, 2011

• FDA Approves Banzel (rufinamide) Oral Suspension, 40 mg/mL
• Banzel (rufinamide) FDA Approval History

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

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

Promacta (eltrombopag)

New Indication Approved: November 16, 2012

• FDA Approves New Indication for Promacta (eltrombopag)
• Promacta (eltrombopag) FDA Approval History

Promacta (eltrombopag)

New Indication Approved: August 26, 2014

• FDA Approves New Indication for Promacta (eltrombopag) for Severe Aplastic Anemia
• Promacta (eltrombopag) FDA Approval History

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

Promacta (eltrombopag)

Patient Population Altered: June 12, 2015

• FDA Approves Promacta for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication
• Promacta (eltrombopag) FDA Approval History

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