Medication Guide App

New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

November 2008

November 3

Treanda (bendamustine hydrochloride)

New Indication Approved: October 31, 2008

Treanda (bendamustine hydrochloride) FDA Approval History

November 6

Crestor (rosuvastatin calcium)

New Indication Approved: November 6, 2008

November 6

Ranexa (ranolazine)

New Indication Approved: November 5, 2008

Ranexa (ranolazine) FDA Approval History

November 11

Cardene (nicardipine)

New Formulation Approved: November 7, 2008

November 12

Focalin XR (dexmethylphenidate)

Labeling Revision Approved: October 17, 2008

Focalin XR (dexmethylphenidate) FDA Approval History

November 13

Premarin Vaginal Cream (conjugated estrogens)

New Indication Approved: November 7, 2008

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.

Banzel (rufinamide) FDA Approval History

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.

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.

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.

SCE-A (Synthetic Conjugated Estrogens-A) FDA Approval History

March 4

Banzel (rufinamide)

New Dosage Form Approved: March 3, 2011

Banzel (rufinamide) FDA Approval History

August 26

Nucynta (tapentadol)

New Dosage Form Approved: August 25, 2011

Nucynta (tapentadol) FDA Approval History

August 29

Nucynta (tapentadol)

New Indication Approved: August 28, 2012

Nucynta (tapentadol) FDA Approval History

November 19

Promacta (eltrombopag)

New Indication Approved: November 16, 2012

Promacta (eltrombopag) FDA Approval History

August 26

Promacta (eltrombopag)

New Indication Approved: August 26, 2014

Promacta (eltrombopag) FDA Approval History

Hide
(web1)