Filed Under (Mental Disorders) by David on 31-01-2010
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Two new indications are now approved for aripiprazole (Abilify), an atypical antipsychotic agent.
Otsuka and Bristol-Myers Squibb have announced the approval of their sNDA for aripiprazole to treat positive and negative symptoms of schizophrenia in adolescents 13 to 17 years of age. Aripiprazole was first approved for the treatment of schizophrenia in adults in 2002.
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Filed Under (Blood Pressure) by David on 30-01-2010
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The FDA has approved an sNDA for irbesartan/hydrochlorothiazide (HCT) (Avalide drug, Sanofi-Aventis/Bristol-Myers Squibb) for initial use in patients with hypertension who might need several drugs to achieve blood pressure goals. This is the first combination drug indicated for the first-line treatment of mod-erate-to-severe hypertension. Until now, Avalide was approved only if an initial hypertension treatment did not work.
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Filed Under (Anti Viral, Cancer) by David on 29-01-2010
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A supplemental New Drug Application (sNDA) has been approved for sorafenib tablets (Nexavar, Bayer/Onyx) to treat unresectable hepatocellular carcinoma. This form of liver cancer is responsible for almost 90% of primary malignant liver tumors in adults.
Hepatocellular carcinoma is extremely aggressive. If the cancer isn’t removed completely through surgery, patients usually die within six months.
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Filed Under (Surgery) by David on 28-01-2010
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Despite appropriate antibiotic therapy and modern echocardiographic and cardiac surgical approaches, mortality rates remain high (at 20%) for patients with Staphylococcus aureus-infective endocarditis (SAIE). The ICE Investigators, an international group of researchers, suggest that it might be time to bring aspirin to the front line. They found that the recent use of acetylsalicylic acid was associated with a significantly lower overall rate of acute valve replacement surgery, particularly when valvular regurgitation, congestive heart failure, or periannular abscess was the indication for surgery.
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Filed Under (Women's Health) by David on 27-01-2010
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Deciding which patients can safely discontinue anticoagulation therapy is an unresolved problem in managing venous thromboembolism (VTE), according to researchers for the AESOPUS group.
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Filed Under (Diabetes) by David on 26-01-2010
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Some vials of the long-acting insulin detemir (Levemir, Novo Nordisk) that had been stolen have reappeared and are being sold in the U.S. market. Three lots (a total of 129,000 vials) of this product were stolen. It’s possible that these vials were not stored or handled properly and that they might be dangerous for patients to use. The FDA received one report of an adverse event caused by poor control of glucose levels after a patient used a vial from one of these three lots.
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Filed Under (Anti Viral) by David on 25-01-2010
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The FDA is warning health care professionals of liver injury associated with the use of the antithyroid propylthiouracil (PTU) for the treatment of Graves’ disease. An increased risk of liver damage was identified with this drug when compared with methimazole, an alternative therapy for Graves’ disease.
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