FDA approves first weight-loss treatment in over a decade
June 28th 2012FDA has approved lorcaserin (Belviq, Arena Pharmaceuticals and Eisai) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients who are overweight or obese and have at least 1 weight-related comorbid condition. It is the first prescription weight-loss treatment approved by FDA in 13 years.
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FDA issues complete response letter for stroke indication for apixaban
June 25th 2012FDA issued a complete response letter for a New Drug Application for apixaban (Eliquis, Bristol-Myers Squibb) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
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FDA issues complete response letter for ACS indication for rivaroxaban
June 22nd 2012FDA issued a complete response letter regarding a supplemental New Drug Application for rivaroxaban (Xarelto, Janssen Research & Development) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome.
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AMCP pleased with revised PDUFA
June 22nd 2012The Academy of Managed Care Pharmacy strongly favors the revisions of the Prescription Drug User Fee Act (PDUFA) that the US House of Representatives and the US Senate conference committee negotiated earlier this week and the House passed by voice vote on Wednesday.
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Dabigatran prescribing information is updated
June 22nd 2012Label prescribing information for dabigatran (Pradaxa, Boehringer Ingelheim) capsules has been updated to affirm that the 150-mg twice-daily dose is superior to warfarin in reducing ischemic and hemorrhagic strokes in patients with nonvalvular atrial fibrillation.
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MTX injection not superior to oral administration in juvenile idiopathic arthritis
June 22nd 2012Injections of methotrexate were not superior to oral therapy in long-term treatment of patients with juvenile idiopathic arthritis, according to a new study, published in the May 30 online edition of Arthritis Care & Research.
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Combination therapy more effective than metformin alone for treating youth with type 2 diabetes
June 22nd 2012A combination of 2 diabetes drugs, metformin and rosiglitazone (Avandia, GlaxoSmithKline), was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a study funded by the National Institutes of Health has found.
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Predicting health exchange models
June 15th 2012As the Supreme Court debates the constitutionality of the Patient Protection and Affordable Care Act, some states are taking a wait-and-see attitude on health insurance exchange implementation, while others are forging ahead. Meanwhile, private exchanges are gaining some traction.
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Safety information for children missing on many drug labels
June 15th 2012Approximately half of drug labels don’t have information on the medication’s safety and proper dosing in children, revealing an overall lack of study of children’s drug therapies, according to a study from FDA researchers.
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Daily vitamin D (≤400 IU) and calcium (1,000 mg) supplements for the primary prevention of fractures in postmenopausal women are no longer recommended as they don’t help prevent fractures and may cause harm, according to draft guidance from the US Preventive Services Task Force.
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FDA approves pertuzumab for treatment of HER2-positive metastatic breast cancer
June 11th 2012FDA has approved pertuzumab (Perjeta, Roche) in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
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Sandoz recalls some lots of generic Introvale due to packaging error
June 7th 2012Sandoz, a division of Novartis, is voluntarily recalling 10 lots of its generic oral contraceptive Introvale (levonorgestrel and ethinyl estradiol) tablets in the United States, after a consumer reported a packaging flaw.
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