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New Drug Approvals Archive - November 2008

November 2008

Crestor (rosuvastatin calcium)

New Indication Approved: November 6, 2008

Ranexa (ranolazine)

New Indication Approved: November 5, 2008

Read more: Ranexa (ranolazine) FDA Approval History

Focalin XR (dexmethylphenidate)

Labeling Revision Approved: October 17, 2008

Read more: Focalin XR (dexmethylphenidate) FDA Approval History

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.

Read more: 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.

Read more: 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.

Read more: 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.

Read more: SCE-A (Synthetic Conjugated Estrogens-A) FDA Approval History

Promacta (eltrombopag)

New Indication Approved: November 16, 2012

Read more: Promacta (eltrombopag) FDA Approval History

New Drug Approvals Archive