FDA issues second complete response letter for Xarelto
March 5th 2013FDA has issued a second complete response letter regarding a supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Janssen) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS).
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Colonoscopy screening reduces risk of advanced colorectal cancer
March 5th 2013A new study led by a researcher at the Perelman School of Medicine at the University of Pennsylvania adds support to current medical recommendations stating that screening colonoscopy substantially reduces an average-risk adult’s likelihood of being diagnosed with advanced colorectal cancer (CRC) in either the right or left side of the colon.
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For season flu use antivirals regardless of vaccination status
March 4th 2013The 2012/2013 seasonal influenza vaccine is moderately effective at preventing medically attended influenza. However, some vaccinated people may still become infected, so clinicians should use antivirals as recommended by CDC regardless of vaccination status, according to estimates published in Morbidity and Mortality Weekly Report (MMWR), February 22, 2013.
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Recent FDA action (through February 2013) related to, rintatolimod, insulin degludec, insulin degludec/insulin aspart, dolutegravir, Radium-223 dichloride, APG101, LG631-CD34, Placental eXpanded, buprenorphine hydrochloride, naloxone HCI dihydrate, doxorubicin hydrochloride, clindamycin in 5% dextrose, Adderall
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FDA Actions in Brief February 2013
February 28th 2013Recent FDA Approvals (through February 2013) related to (Ado-trastuzumab, Kadcyla, Genentech, Everolimus, Zortress, Novartis, Adapalene, benzoyl peroxide, Epiquo, Galderma, pomalidomide, Pomalyst, Celgene, alogliptin, Nesina, Takeda Pharmaceuticals, Kazano, Oseni, imatinib, Gleevec, mesalamine, Delzicol, Warner Chilcott, mipomersen sodium, Kynamro, Genzyme, Isis Pharmaceuticals, Merck, Oxutrol for Women, glycerol phenylbutyrate, Ravicti, Hyperion Therapeutics, pneumococcal 13-valent Conjugate Vaccine, Prevnar 13, Pfizer
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An update in attention deficit/hyperactivity disorder
February 28th 2013Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder in children. New formulations of stimulants and nonstimulants allow for individualization of therapy for patients to receive the maximum benefit while minimizing side effects.
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Community-based intervention can help reduce mortality from opioid overdose
February 28th 2013In the study of communities in Massachusetts with high numbers of opioid overdose deaths, implementation of overdose education and naloxone distribution (OEND) were associated with a significant reduction in opioid overdose death rates.
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