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In this issue
Orphan drugs
Antiplatelet agents
Adverse events
Rotavirus vaccine
Key Topic Updates

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FEBRUARY 12, 2010
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Drugs for orphan diseases seeing more FDA approvals
Federal regulatory agencies are signing off on more new product approvals for treatment of so-called neglected diseases in recent years. One reason for the rise in approvals may be tied to increased research and development (R&D) funding available, report researchers at the Tufts Center for the Study of Drug Development (CSDD) in the November/December Tufts CSDD Impact Report. More...
Two new antiplatelet agents go head to head with clopidogrel in the setting of PCI
Two investigational competitors to clopidogrel took their shots against the antiplatelet giant in 3 separate randomized controlled phase 3 trials of patients undergoing percutaneous coronary intervention (PCI). The studies indicate that cangrelor prior to PCI was not superior to clopidogrel in this setting, whereas ticagrelor prevented more deaths and ischemic events than clopidogrel in patients with ST-elevation myocardial infarction (STEMI) who underwent PCI. More...
Users of PIMs may be at risk for more adverse events, health costs
Older adults who take specific potentially inappropriate medications (PIMs) may raise their chances of adverse events as well as increase their healthcare costs, according to a new study published in the January issue of the American Journal of Managed Care. More...
Rotavirus vaccination may lessen occurrence of gastroenteritis in small children
In the first year of a child’s life, immunization with a rotavirus vaccine (Rotarix, GlaxoSmithKline) may markedly lower incidence of severe virus gastroenteritis. Subsequently, the immunization may lead to notable reduction in diarrhea-triggered deaths in children under age 5, according to results of two studies published in the January 28 issue of the New England Journal of Medicine. More...
Key Topic Updates
FDA Approvals
Pralatrexate injection (Folotyn): Folate analogue metabolic inhibitor approved for treatment of relapsed or refractory peripheral T-cell lymphoma
FDA actions in brief, January 2010 (Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate)
First-time generic approvals, January 2010
In the Pipeline
FDA Pipeline preview, January 2010 (Testosterone undecanoate injection, Telavancin, Ampligen, Doxepin, Everolimus, Aztreonam lysine, Erlotinib, TG4010, BSI-201, Midazolam, Aimspro, Motorgraft, BHR-100, Dextran sulfate)
Medication Safety
FDA's Safe Use Initiative to address preventable harm due to medication misuse, errors, and other related problems
Exenatide drug label to include information on post-marketing surveillance of altered kidney function

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