New Drug Approvals: May 2005

Date of Approval: May 2, 2005

Company: Baxter Healthcare Corporation

Treatment for Primary Immunodeficiency Syndrome

Gammagard Liquid 10% is a ready-to-use, sterile preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. Gammagard Liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.

Date of Approval: May 3, 2005

Company: GlaxoSmithKline Biologicals

Treatment for Diphtheria Prophylaxis, Pertussis Prophylaxis, Tetanus Prophylaxis

Boostrix is indicated as a single dose active booster immunization against tetanus, diphtheria, and pertussis in individuals 10 through 18 years of age, thereby adding a pertussis component to the routine tetanus/diphtheria booster currently administered to teens.

Company: Biovail Corporation

Treatment for Moderate to Moderately Severe Pain

Company: SkyePharma PLC

Treatment for Lipid Disorders

Company: Depomed, Inc.

Treatment for Uncomplicated Urinary Tract Infections

Company: Abbott

Treatment for Secondary Hyperparathyroidism in Kidney Disease

Date of Approval: May 26, 2005

Company: Novartis Pharmaceuticals Corporation

Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD)

Focalin XR is a once-daily extended-release form of Focalin indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children.

Date of Approval: May 31, 2005

Company: BioMarin Pharmaceutical Inc.

Treatment for Mucopolysaccharidosis Type VI

Naglazyme (formerly rhASB) is an enzyme-replacement therapy for treatment of mucopolysaccharidosis VI (MPS VI), an inherited, life-threatening lysosomal storage disorder caused by a deficiency of the lysosomal enzyme N-acetylgalactosamine 4-sulfatase (also known as arylsulfatase B).