FDA issues CRL for obesity treatment due to concerns about cardiovascular safety
February 2nd 2011FDA has issued a complete response letter for Orexigen?s and Takeda?s Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
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The recently FDA-approved oral direct thrombin inhibitor, dabigatran, may be cost-effective compared to the standard-of-care therapy of adjusted-dose warfarin in patients requiring anticoagulation for stroke prevention in atrial fibrillation, according to a pharmacoeconomic evaluation published in the Annals of Internal Medicine.
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FDA faces congressional probes and more transparency and organizational changes
February 1st 2011With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are contemplating broad federal budget cuts and much more aggressive oversight of administration health policy and regulatory programs.
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FDA: Dolasetron mesylate IV no longer indicated for CINV
February 1st 2011Intravenous dolasetron mesylate (Anzemet) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in adult or pediatric patients due to an associated dose-dependant increase in QTc prolongation, according to a recent FDA drug safety communication.
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Study finds different opioids offer variable safety in older adults with noncancer pain
February 1st 2011Different opioids had different safety profiles when administered to older adults for noncancer pain, according to results from a new study published in the Archives of Internal Medicine.
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Recombinant HPV Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
February 1st 2011New indication: Recombinant HPV quadrivalent (types 6, 11, 16, and 18) vaccine (Gardasil) was approved for the prevention of anal cancer and associated precancerous lesions due to HPV in persons aged 9 to 26 years.
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