New Drug Approvals: May 2005

Date of Approval: May 2, 2005

Company: Baxter Healthcare Corporation

Treatment for: Primary Immunodeficiency Syndrome

Gammagard (immune globulin intravenous) is a ready-to-use, sterile preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. Gammagard 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 a combination vaccine that provides a booster immunization against pertussis (whooping cough) in combination with tetanus and diphtheria.

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 (galsulfase) 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).

Labeling Revision Approved: October 17, 2008

Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

Patient Population Altered: December 4, 2008