New Drug Approvals

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  • Vasovist (gadofosveset trisodium) - formerly MS-325
    Date of Approval: December 22, 2008
    Company: EPIX Pharmaceuticals, Inc.
    Treatment for: Diagnostic
    Vasovist (gadofosveset trisodium) is a blood pool magnetic resonance angiography (MRA) agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
  • ZolpiMist (zolpidem tartrate) Oral Spray
    Date of Approval: December 22, 2008
    Company: NovaDel Pharma, Inc.
    Treatment for: Insomnia
    ZolpiMist is an oral spray formulation of zolpidem, the drug contained in Ambien. ZolpiMist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
  • Oral Fludarabine (fludarabine phosphate) Tablets
    Date of Approval: December 19, 2008
    Company: Antisoma plc
    Treatment for: Chronic Lymphocytic Leukemia
    Oral fludarabine (fludarabine phosphate) is an oral nucleoside analogue approved as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL).
  • Mozobil (plerixafor)
    Date of Approval: December 15, 2008
    Company: Genzyme Corporation
    Treatment for: Bone Marrow Transplantation
    Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.
  • Trilipix (fenofibric acid) Delayed-Release Capsules
    Date of Approval: December 15, 2008
    Company: Abbott
    Treatment for: Hypertriglyceridemia, Hyperlipidemia
    Trilipix (fenofibric acid) is a peroxisome proliferator receptor alpha (PPARĪ±) activator indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin.
  • Lusedra (fospropofol disodium) Injection - formerly Aquavan
    Date of Approval: December 12, 2008
    Company: Eisai Corporation of North America
    Treatment for: Sedation
    Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.
  • Tapentadol Immediate Release Tablets
    Date of Approval: November 20, 2008
    Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Treatment for: Pain
    Tapentadol is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.
  • Toviaz (fesoterodine fumarate) Extended Release Tablets
    Date of Approval: October 31, 2008
    Company: Pfizer Inc.
    Treatment for: Urinary Frequency
    Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
  • Vimpat (lacosamide) Tablets and Injection
    Date of Approval: October 28, 2008
    Company: UCB
    Treatment for: Seizures
    Vimpat (lacosamide) is an anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy.

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