New Drug Approvals Archive

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December 2004

December 10

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.

Equetro (carbamazepine) FDA Approval History

December 14

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.

Zylet (loteprednol and tobramycin) FDA Approval History

December 15

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).

Lunesta (eszopiclone) FDA Approval History

December 15

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.

Kepivance (palifermin) FDA Approval History

December 17

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.

Macugen (pegaptanib) FDA Approval History

December 17

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.

depo-subQ provera 104 (medroxyprogesterone acetate) FDA Approval History

December 22

Enablex (darifenacin) Extended-Release Tablets

Date of Approval: December 22, 2004
Company: Novartis Pharmaceuticals Corporation
Treatment for: Overactive Bladder

Enablex (darifenacin) is a muscarinic receptor antagonist indicated for the treatment of overactive bladder.

Enablex (darifenacin) FDA Approval History

December 28

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).

Clolar (clofarabine) FDA Approval History

December 28

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.

Prialt (ziconotide) FDA Approval History

December 29

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.

Ventavis (iloprost) FDA Approval History

December 30

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.

Lyrica (pregabalin) FDA Approval History

June 22

Lyrica (pregabalin)

New Indication Approved: June 21, 2007

Lyrica (pregabalin) FDA Approval History

June 21

Lyrica (pregabalin)

New Indication Approved: June 20, 2012

Lyrica (pregabalin) FDA Approval History

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