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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Pediatric treatments for allergic ocular diseases improve
February 28th 2013Recent advances in treatments of allergic ocular diseases are available to help relieve the signs and symptoms in pediatric patients. Stephen C. Pflugfelder, MD, described those treatments in a symposium during the recent annual meeting of the American Academy of Ophthalmology, in Chicago
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USPSTF guideline may remove financial barriers to routine HIV testing
February 28th 2013Proposed HIV-testing guidelines by the U.S. Preventive Services Task Force (USPSTF) will remove financial barriers to routine HIV screening by eliminating out-of-pocket costs, according to a perspective article in the March 7 issue of the New England Journal of Medicine.
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FDA approves treatment for postmenopausal women experiencing pain during intercourse
February 27th 2013FDA has approved ospemifene (Osphena, Shionogi) tablets for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
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Extended dabigatran use reduces risk of recurrent VTE, study finds
February 27th 2013Dabigatran used beyond the initial 3 months of treatment at a dose of 150 mg twice daily reduced the risk of recurrent venous thromboembolism (VTE), according to a study published February 21 in the New England Journal of Medicine.
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Regular vitamin C supplementation does little for incidence of colds
February 26th 2013The age-old wisdom that vitamin C can help reduce the incidence of colds recently had another set back in a study from Finland, published in Cochrane Database of Systemic Reviews at the end of January 2013.
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FDA warns about codeine for childrens’ postop pain
February 26th 2013FDA is adding its strongest warning to labels of codeine-containing products advising against their use for pain relief in children after surgery to remove tonsils or adenoids. The agency asks healthcare professionals to use alternate pain relievers instead.
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Veterans diagnosed with reflux issues often start on high doses of PPIs, rarely stop therapy
February 26th 2013US veterans diagnosed with gastroesophageal reflux disease (GERD) are frequently prescribed doses of proton pump inhibitors (PPIs) that are much higher than recommended, according to a new study, published in the February 16, 2013 issue of Journal of General Internal Medicine.
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