New Drug Approvals
- 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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