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FDA actions in brief, February 2009 (Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, AllerNaze)


Recent FDA approvals (through Feburary 2009) related to Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, and AllerNaze

Gadofosveset (Vasovist, Epix) was approved for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease.

Fospropofol injection (Lusedra, Eisai) was approved for monitored anesthesia care sedation in adult patients undergoing diagnostic or therapeutic procedures.

Lidocaine monohydrate powder intradermal injection system (Zingo, Anesiva) was approved for the treatment of pain associated with blood draws in adults.

A new formulation of amiodarone injection (Nexterone, Prism) was approved for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

Zolpidem oral spray (Zolpimist, NovaDel) was approved for the short-term treatment of insomnia characterized by difficulties with sleep initiation. FDA approved fenofibric acid (Trilipix, Abbott) for use with a statin to reduce triglycerides (TG) and increase high-density lipoprotein cholesterol (HDL-C) in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent who are taking optimal statin therapy to achieve low-density lipoprotein (LDL) goals. This agent was also approved as monotherapy to reduce TG in patients with severe hypertriglyceridemia and to reduce elevated LDL-C, total cholesterol, TG, and Apo B and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia.

Tramadol once-daily extended-release tablets (Ryzolt, Labopharm) were approved for the management of moderate-to-severe chronic pain in adults who require around-the-clock treatment of pain for an extended period of time.

FDA approved a combination of adapalene 0.1% and benzoyl peroxide 2.5% (EpiduoGel, Galderma) for the treatment of acne.

A tablet formulation of fludarabine (Antisoma) was approved for the second-line treatment of chronic lymphocytic leukemia.

Triamcinolone acetonide nasal spray (AllerNaze, Collegium) was approved for the once-daily treatment of nasal symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis in adults and children aged ≥12 years. This agent was previously called Tri-Nasal.

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