New Drug Approvals Archive - December 2004
December 2004
Equetro (carbamazepine) Extended-Release Capsules
Date of Approval: December 10, 2004
Company: Shire Pharmaceuticals Group plc
Treatment for: Bipolar Disorder
Equetro (carbamazepine) is an extended-release anticonvulsant indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder.
Zylet (loteprednol and tobramycin) Ophthalmic Suspension
Date of Approval: December 14, 2004
Company: Bausch & Lomb
Treatment for: Uveitis, Iritis, Bacterial Conjunctivitis, Keratitis, Cyclitis
Zylet (loteprednol etabonate and tobramycin ophthalmic suspension) a topical anti-inflammatory corticosteroid and antibiotic combination for use in the treatment of inflammatory ocular conditions.
Lunesta (eszopiclone) Tablets - formerly Estorra
Date of Approval: December 15, 2004
Company: Sepracor Inc.
Treatment for: Insomnia
Lunesta (eszopiclone) is a nonbenzodiazepine hypnotic agent indicated for the treatment of patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night (sleep maintenance difficulty).
Kepivance (palifermin) Injection
Date of Approval: December 15, 2004
Company: Amgen Inc.
Treatment for: Mucositis
Kepivance (palifermin) is a recombinant human keratinocyte growth factor indicated to decrease the incidence and duration of severe oral mucositis.
Macugen (pegaptanib) Ophthalmic Injection
Date of Approval: December 17, 2004
Company: Eyetech / Pfizer Inc
Treatment for: Macular Degeneration
Macugen (pegaptanib) is a selective vascular endothelial growth factor (VEGF) antagonist indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), an eye disease associated with aging that destroys central vision.
depo-subQ provera 104 (medroxyprogesterone acetate) Injection
Date of Approval: December 17, 2004
Company: Pfizer Inc.
Treatment for: Contraception
depo-subQ provera 104 (medroxyprogesterone acetate) is a lower dose, subcutaneous formulation of Depo Provera indicated for the prevention of pregnancy in women of child bearing potential.
Enablex (darifenacin) Extended-Release Tablets
Date of Approval: December 22, 2004
Company: Allergan, Inc.
Treatment for: Overactive Bladder
Enablex (darifenacin) is a muscarinic receptor antagonist indicated for the treatment of overactive bladder.
Clolar (clofarabine) for Intravenous Infusion
Date of Approval: December 28, 2004
Company: Genzyme Corp.
Treatment for: Acute Lymphoblastic Leukemia
Clolar (clofarabine) is a purine nucleoside anti-metabolite indicated for the treatment of children with refractory or relapsed acute lymphoblastic leukemia (ALL).
Prialt (ziconotide) Intrathecal Infusion
Date of Approval: December 28, 2004
Company: Elan Corporation, plc
Treatment for: Pain
Prialt (ziconotide) is a non-opioid intrathecal (IT) therapy indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.
Ventavis (iloprost) Inhalation Solution
Date of Approval: December 29, 2004
Company: CoTherix, Inc.
Treatment for: Pulmonary Hypertension
Ventavis (iloprost) inhalation solution is synthetic analogue of prostacyclin PGIB2B indicated for the treatment of pulmonary arterial hypertension.
Lyrica (pregabalin) Capsules
Date of Approval: December 30, 2004
Company: Pfizer Inc.
Treatment for: Neuropathic Pain, Postherpetic Neuralgia, Fibromyalgia, Diabetic Neuropathy, Epilepsy
Lyrica (pregabalin) is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and spinal cord injury; as an adjunctive therapy for partial onset seizures and for the treatment of fibromyalgia.
New Drug Approvals Archive
- 2021
- January, February, March
- 2020
- January, February, March, April, May, June, July, August, September, October, November, December
- 2019
- January, February, March, April, May, June, July, August, September, October, November, December
- 2018
- January, February, March, April, May, June, July, August, September, October, November, December
- 2017
- January, February, March, April, May, June, July, August, September, October, November, December
- 2016
- January, February, March, April, May, June, July, August, September, October, November, December
- 2015
- January, February, March, April, May, June, July, August, September, October, November, December
- 2014
- January, February, March, April, May, June, July, August, September, October, November, December
- 2013
- January, February, March, April, May, June, July, August, September, October, November, December
- 2012
- January, February, March, April, May, June, July, August, September, October, November, December
- 2011
- January, February, March, April, May, June, July, August, October, November, December
- 2010
- January, February, March, April, May, June, July, August, September, October, November, December
- 2009
- January, February, March, April, May, June, July, August, September, October, November, December
- 2008
- January, February, March, April, May, June, July, August, September, October, November, December
- 2007
- January, February, March, April, May, June, July, August, September, October, November, December
- 2006
- January, February, March, April, May, June, July, August, September, October, November, December
- 2005
- January, February, March, April, May, June, July, August, September, October, November, December
- 2004
- January, February, March, April, May, June, July, August, September, October, November, December
- 2003
- January, February, March, April, May, June, July, August, September, October, November, December
- 2002
- January, February, April, May, July, August, October, November, December
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.