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FDA actions in brief, September 2008


Recent FDA approvals and indications (through September 2008) related to Diovan HCT, Exforge, Cleviprex, Eovist, Stavzor, Promus Everolimus-Eluting stent, and Xience V Everolimus-Eluting stent

Single-pill combinations of valsartan and hydrochlorothiazide (Diovan HCT, Novartis) and amlodipine and valsartan (Exforge, Novartis) were approved as initial treatment for hypertension in patients likely to need multiple drugs to achieve blood pressure goals.

FDA approved valproic acid delayed-release capsules (Stavzor, Noven) for the treatment of manic episodes associated with bipolar disorder, as monotherapy and as adjunctive therapy for the treatment of complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches. Clevidipine injectable emulsion (Cleviprex, The Medicines Company) was approved for the reduction of blood pressure when oral therapy is not feasible or not desirable.

Gadoxetate intravenous (IV) injection (Eovist, Bayer) was approved for use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

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