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.
AstraZeneca, Daiichi Sankyo Submit New BLA for Datopotamab in Lung Cancer
November 12th 2024After feedback from the FDA, the companies have voluntarily withdrawn the previous biologics licensing application for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous non-small cell lung cancer.
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Skyrizi Overtakes Humira in U.S. Sales Numbers
November 8th 2024For the first time, Skyrizi has replaced Humira as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
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