New Drug Approvals Archive - May 2005

Vaccinia (vaccinia immune globulin intravenous (human)) Injection

Date of Approval: May 2, 2005
Company: DynPort Vaccine Company LLC
Treatment for: Smallpox Vaccine Reaction

Vaccinia Immune Globulin Intravenous (Human) (VIGIV) indicated for the treatment of complications from smallpox vaccination

• Vaccinia DynPort Vaccine Company LLC - Treatment for Complications of Smallpox Vaccination

Vaccinia (vaccinia immune globulin intravenous (human)) FDA Approval History

Gammagard Liquid (immune globulin infusion (human)) Solution

Date of Approval: May 2, 2005
Company: Baxter Healthcare Corporation
Treatment for: Primary Immunodeficiency Syndrome

Gammagard (immune globulin infusion (human)) is an immune globulin infusion (human) indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.

• Gammagard Liquid Baxter Healthcare Corporation - Treatment for Primary Immunodeficiency Disorders

Gammagard Liquid (immune globulin infusion (human)) FDA Approval History

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap))

Date of Approval: May 3, 2005
Company: GlaxoSmithKline Biologicals
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis

Boostrix is a combination vaccine that provides a booster immunization against pertussis (whooping cough) in combination with tetanus and diphtheria.

• Boostrix GlaxoSmithKline Biologicals - Treatment for Prevention of Diphtheria, Tetanus & Pertussis in Adolescents

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) FDA Approval History

Triglide (fenofibrate) Tablets

Date of Approval: May 7, 2005
Company: SkyePharma PLC
Treatment for: Hyperlipoproteinemia, Hyperlipoproteinemia Type IIa (Elevated LDL), Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL), Hyperlipoproteinemia Type IV (Elevated VLDL), Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL), Hypertriglyceridemia

Triglide (fenofibrate) is a lipid-regulating agent for the treatment of hypercholesterolemia and hypertriglyceridemia.

• Triglide SkyePharma PLC - Treatment for Lipid Disorders

Triglide (fenofibrate) FDA Approval History

Proquin XR (ciprofloxacin) Extended-Release Tablets

Date of Approval: May 19, 2005
Company: Depomed, Inc.
Treatment for: Urinary Tract Infection

Proquin XR (ciprofloxacin) is an extended release fluoroquinolone antibiotic indicated for the treatment of urinary tract infections.

• Proquin XR Depomed, Inc. - Treatment for Uncomplicated Urinary Tract Infections

Proquin XR (ciprofloxacin) FDA Approval History

Focalin XR (dexmethylphenidate) Extended-Release Capsules

Date of Approval: May 26, 2005
Company: Novartis Pharmaceuticals Corporation
Treatment for: Attention Deficit Disorder

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

• Focalin XR Novartis Pharmaceuticals Corporation - Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD)

Focalin XR (dexmethylphenidate) FDA Approval History

Naglazyme (galsulfase) - formerly Aryplase

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).

• Naglazyme BioMarin Pharmaceutical Inc. - Treatment for Mucopolysaccharidosis VI (MPS VI)

Naglazyme (galsulfase) FDA Approval History

Focalin XR (dexmethylphenidate)

Labeling Revision Approved: October 17, 2008

• FDA Approves 30-Minute Onset of Action for Focalin XR

Focalin XR (dexmethylphenidate) FDA Approval History

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap))

Patient Population Altered: December 4, 2008

• FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough Vaccine, Boostrix, for Adults

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) FDA Approval History

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap))

Patient Population Altered: July 8, 2011

• FDA approves Boostrix to prevent tetanus, diphtheria, and pertussis in older people

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) FDA Approval History

Gammagard Liquid (immune globulin infusion (human))

New Dosage Form Approved: July 22, 2011

• Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid for Patients with Primary Immunodeficiency

Gammagard Liquid (immune globulin infusion (human)) FDA Approval History

Gammagard Liquid (immune globulin infusion (human))

New Indication Approved: June 25, 2012

• Baxter Announces FDA Approval for Gammagard Liquid as a Treatment for Multifocal Motor Neuropathy

Gammagard Liquid (immune globulin infusion (human)) FDA Approval History