New Drug Approvals Archive - January 2005

Abraxane (paclitaxel protein-bound) for Injectable Suspension

Date of Approval: January 7, 2005
Company: American Pharmaceutical Partners, Inc. / American Bioscience, Inc.
Treatment for: Breast Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer

Abraxane (paclitaxel protein-bound) is an albumin-bound form of the antineoplastic agent paclitaxel indicated for the treatment of breast cancer, non-small cell lung cancer, and pancreatic cancer.

• Abraxane American Pharmaceutical Partners, Inc. / American Bioscience, Inc. - Treatment for Metastatic Breast Cancer
• Abraxane (paclitaxel protein-bound) FDA Approval History

ThyroShield (potassium iodide) Oral Solution

Date of Approval: January 12, 2005
Company: Fleming & Company
Treatment for: Radiation Emergency

ThyroShield (potassium iodide) is used to protect the thyroid gland from the effects of radiation from inhaled or swallowed radioactive iodine.

• ThyroShield Fleming & Company - Treatment for Thyroid Protection in a Radiation Emergency
• ThyroShield (potassium iodide) FDA Approval History

Menactra (meningococcal conjugate vaccine)

Date of Approval: January 14, 2005
Company: Sanofi Pasteur
Treatment for: Meningococcal Meningitis Prophylaxis

Menactra (meningococcal conjugate vaccine) is a quadrivalent conjugate vaccine indicated for the prevention of meningococcal disease.

• Menactra Sanofi Pasteur - Treatment for Protection Against Meningococcal Disease
• Menactra (meningococcal conjugate vaccine) FDA Approval History

Niravam (alprazolam) Orally Disintegrating Tablets

Date of Approval: January 19, 2005
Company: Schwarz Pharma AG
Treatment for: Anxiety, Panic Disorder

Niravam (alprazolam) is an orally disintegrating benzodiazepine indicated for the short-term relief of anxiety and panic attacks.

• Niravam Schwarz Pharma AG - Treatment for Anxiety Disorders
• Niravam (alprazolam) FDA Approval History

Eloxatin (oxaliplatin)

New Formulation Approved: January 31, 2005

• Eloxatin Sanofi-Synthelabo - Treatment for Advanced Carcinoma of the Colon or Rectum

Nascobal (cyanocobalamin)

New Formulation Approved: January 31, 2005

• Nascobal Nastech Pharmaceutical Company Inc. - Treatment for Vitamin B12 Deficiency
• Nascobal (cyanocobalamin) FDA Approval History

Menactra (meningococcal conjugate vaccine)

Patient Population Altered: April 22, 2011

• FDA Approves Menactra to Prevent Meningococcal Disease in Infants and Toddlers
• Menactra (meningococcal conjugate vaccine) FDA Approval History

Abraxane (paclitaxel protein-bound)

New Indication Approved: October 11, 2012

• FDA Approves Abraxane for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
• Abraxane (paclitaxel protein-bound) FDA Approval History

Abraxane (paclitaxel protein-bound)

New Indication Approved: September 6, 2013

• FDA Approves Abraxane for Late-Stage Pancreatic Cancer
• Abraxane (paclitaxel protein-bound) FDA Approval History