FDA: Guidance on development of abuse-deterrent opioid formulations
January 31st 2013FDA issued a draft guidance last month to help the industry in the development of opioid drug formulations with abuse-deterrent properties, saying it considers development of these products a high public health priority.
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Clarithromycin may increase miscarriage risk
January 29th 2013The use of clarithromycin in the first trimester of pregnancy may increase the risk of miscarriage, according to researchers in Denmark. However, the researchers did not find a link between exposure to clarithromycin and major congenital malformations.
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FDA panel seeks tighter controls on hydrocodone-containing products
January 28th 2013An FDA advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs such as Vicodin, Lortab, and Norco into the more restrictive Schedule II category of controlled substances, MedPage Today reported.
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FDA approves deferasirox to remove excess iron in patients with genetic blood disorder
January 23rd 2013FDA has expanded the approved use of deferasirox (Exjade, Novartis) to treat patients aged 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).
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Flu vaccine shortage elicits FDA guidance
January 22nd 2013The spike in flu cases over the past month, along with limited supplies of influenza vaccine and Tamiflu across the United States, has led FDA Commissioner Margaret Hamburg to issue guidance to pharmacists and other healthcare providers.
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Study raises concern over cefixime failure rate for gonorrhea
January 21st 2013Researchers examining the effectiveness of cefixime in the treatment of gonorrhea found a relatively high treatment failure rate, raising concern that gonorrhea may become untreatable, according to results published January 9 in the Journal of the American Medical Association.
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FDA approves first migraine patch
January 18th 2013FDA has approved sumatriptan iontophoretic transdermal system (Zecuity, NuPathe) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin.
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FDA’s recent approval of crofelemer (Fulyzaq, Salix Pharmaceuticals, under license from Napo Pharmaceuticals), 125 mg delayed-release tablets, the first anti-diarrheal drug for HIV/AIDS patients taking antiretroviral therapy (ART), is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience noninfectious diarrhea, which often can lead to reduced treatment compliance.
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AMCP urges CMS to evaluate existing quality measures for use in exchanges
January 17th 2013The Academy of Managed Care Pharmacy (AMCP) recommends that the Centers for Medicare & Medicaid Services (CMS) evaluate existing national quality health measures before implementing quality metrics in state health insurance Exchanges starting in 2016.
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FDA approves new seasonal flu vaccine made using novel technology
January 17th 2013FDA approved the first trivalent influenza vaccine (Flublok, Protein Sciences) made using an insect virus (baculovirus) expression system and recombinant DNA technology for the prevention of seasonal influenza disease in people aged 18 to 49 years.
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Merck tells physicians to stop prescribing Tredaptive
January 15th 2013Merck is halting sales of its cholesterol drug-extended-release niacin/laropiprant (Tredaptive)-after preliminary data from a study showed that it did not achieve its primary end point of reduction of major vascular events and also raised safety concerns.
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