New Drug Approvals: November 2004

Company: Abbott Laboratories

Treatment for Lipid Disorders

Date of Approval: November 10, 2004

Company: Reliant Pharmaceuticals, Inc.

Treatment for Hypertriglyceridemia

Omacor, which contains highly concentrated ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is indicated as an adjunct to diet for the reduction of triglycerides in adult patients with very high triglyceride levels.

Date of Approval: November 17, 2004

Company: Boehringer Ingelheim

Treatment for Bronchospasm Prophylaxis

Atrovent HFA is an environmentally friendly version of Atrovent formulated with a non-chlorofluorocarbon (CFC) propellant called HFA (hydrofluoroalkane). Atrovent HFA is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), including chronic bronchitis and emphysema.

Date of Approval: December 31, 1969

Company: OSI/Genentech

Treatment for Non-Small Cell Lung Cancer

Date of Approval: December 31, 1969

Company: OSI/Genentech

Treatment for Non-Small Cell Lung Cancer

Company: Yamanouchi / GlaxoSmithKline

Treatment for Overactive Bladder

Date of Approval: November 23, 2004

Company: Biogen Idec / Elan Corporation, plc

Treatment for Multiple Sclerosis, Crohn's Disease -- Maintenance

Tysabri (natalizumab) is a recombinant humanized IgG4κ monoclonal antibody for the treatment of multiple sclerosis and Crohn's disease.

Date of Approval: November 26, 2004

Company: Forest Laboratories, Inc.

Treatment for Pain

Combunox is a fixed-dose combination of the opioid oxycodone HCl (5 mg) and the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen (400 mg) indicated for the short-term management of acute, moderate to severe pain.

New Indication Approved: November 24, 2004

Date of Approval: November 30, 2004

Company: Reliant Pharmaceuticals, Inc.

Treatment for Heterozygous Familial Hypercholesterolemia, Hypertriglyceridemia

Antara is a lipid-lowering agent approved as adjunctive therapy to diet for the treatment of elevated levels of cholesterol and triglycerides.

Date of Approval: November 30, 2004

Company: KV Pharmaceutical Company

Treatment for Bacterial Vaginosis

Clindesse Vaginal Cream 2% is a single-dose prescription cream therapy indicated to treat bacterial vaginosis.