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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