New Drug Approvals Archive - 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.

• Equetro Shire Pharmaceuticals Group plc - Treatment for Bipolar Disorder

Equetro (carbamazepine) FDA Approval History

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 Bausch & Lomb - Treatment for Inflammatory Ocular Conditions

Zylet (loteprednol and tobramycin) FDA Approval History

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 Sepracor Inc. - Treatment for Insomnia

Lunesta (eszopiclone) FDA Approval History

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 Amgen Inc. - Treatment for Severe Oral Mucositis in Cancer Patients

Kepivance (palifermin) FDA Approval History

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 Eyetech / Pfizer Inc - Treatment for Neovascular (Wet) Age-Related Macular Degeneration

Macugen (pegaptanib) FDA Approval History

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 Pfizer Inc. - Treatment for Prevention of Pregnancy

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

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.

• Enablex Novartis Pharmaceuticals Corporation - Treatment for Overactive Bladder

Enablex (darifenacin) FDA Approval History

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 Genzyme Corp. - Treatment for Leukemia in Children

Clolar (clofarabine) FDA Approval History

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 Elan Corporation, plc - Treatment for Severe Chronic Pain

Prialt (ziconotide) FDA Approval History

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 CoTherix, Inc. - Treatment for Pulmonary Arterial Hypertension

Ventavis (iloprost) FDA Approval History

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 Pfizer Inc. - Treatment for Neuropathic Pain

Lyrica (pregabalin) FDA Approval History

Lyrica (pregabalin)

New Indication Approved: June 21, 2007

• FDA Approves First Drug for Treating Fibromyalgia - Lyrica

Lyrica (pregabalin) FDA Approval History

Lyrica (pregabalin)

New Indication Approved: June 20, 2012

• FDA Approves Lyrica For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review

Lyrica (pregabalin) FDA Approval History