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P&T May 2013

Features

Finding a Better Way to Predict and Prevent Company Closures
To stave off a shortage of doxorubicin in 2011 and 2012, the FDA expedited the approval of a company’s unapproved manufacturing process. Paying companies sufficiently so that they can invest in their facilities when needed is just one of many steps that could be taken to rectify future shortages.
Part 1: Proposed Regulatory Criteria for FDA Approval
Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.
Sequential Conventional Amphotericin B/Lipid Versus Lipid-Only Therapy For the Treatment of Invasive Fungal Infections in Hospitalized Patients
Clinicians who prescribe amphotericin B should keep in mind the potential for nephrotoxicity. Lipid-based formulations can be less toxic than the conventional form but may also be more expensive. Patient outcomes and cost-effectiveness of the various formulations are discussed

Departments

Prescription: Washington
FDA pushes plans for drug compounding

Dimethyl fumarate capsules (Tecfidera) for multiple sclerosis, ado-trastuzumab emtansine injection (Kadcyla) for HER-2–positive breast cancer, and ospemifene tablets (Osphena) for painful intercourse in postmenopausal women

FDA approvals, drug indications, and updates

Meeting Highlights

Dermatology topics include agents for psoriasis, urticaria, and infantile hemangiomas. The pros and cons of antiplatelet drugs prasugrel (Effient) and ticagrelor (Brilinta) are discussed, and an investigational agent, cangrelor, shows promise in reducing ischemic events when compared with clopidogrel (Plavix).