New Drug Approvals: December 2004

Date of Approval: December 2, 2004

Company: Inamed Corp / Genzyme Corp

Treatment for Facial Wrinkle Correction

Captique is a non-animal stabilized hyaluronic acid dermal filler indicated for the correction of moderate to severe facial wrinkles.

Company: Savient Pharmaceuticals, Inc.

Treatment for Osteoarthritis of the Knee

Date of Approval: December 10, 2004

Company: Shire Pharmaceuticals Group plc

Treatment for Bipolar Disorder

Equetro is an extended-release formulation of carbamazepine indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder.

Company: Bausch & Lomb

Treatment for Inflammatory Ocular Conditions

Company: QLT Inc.

Treatment for Advanced Prostate Cancer

Date of Approval: December 15, 2004

Company: Sepracor Inc.

Treatment for Insomnia

Lunesta 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).

Date of Approval: December 15, 2004

Company: Amgen Inc.

Treatment for Mucositis

Kepivance is a recombinant human keratinocyte growth factor indicated to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant.

Date of Approval: December 17, 2004

Company: Eyetech / Pfizer Inc

Treatment for Macular Degeneration

Macugen 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.

Date of Approval: December 17, 2004

Company: Pfizer Inc.

Treatment for Contraception

depo-subQ provera 104 (104 mg/0.65 mL) is a lower dose, subcutaneous formulation of Depo Provera indicated for the prevention of pregnancy in women of child bearing potential.

Company: Hoffmann-La Roche Inc.

Treatment for HIV Infection

Date of Approval: December 22, 2004

Company: Novartis Pharmaceuticals Corporation

Treatment for Overactive Bladder

Enablex is a potent muscarinic receptor antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency.

Date of Approval: December 28, 2004

Company: Genzyme Corp.

Treatment for Acute Lymphoblastic Leukemia

Clolar is a purine nucleoside anti-metabolite indicated for the treatment of children with refractory or relapsed acute lymphoblastic leukemia (ALL).

Company: Elan Corporation, plc

Treatment for Severe Chronic Pain

Company: CoTherix, Inc.

Treatment for Pulmonary Arterial Hypertension

Date of Approval: December 30, 2004

Company: Pfizer Inc.

Treatment for Postherpetic Neuralgia, Fibromyalgia

Lyrica is a 3-substituted analogue of gamma-amino butyric acid (GABA) and a compound related to gabapentin (Neurontin). Lyrica is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). Lyrica is also indicated for the treatment of fibromyalgia.