New Drugs 2009-2010- Pharmacist
The year 2009 held big changes for the Food and Drug Administration (FDA). Proposals sent to Congress called for expanding the agency's budget to $3.2 billion. If enacted, this would be the largest annual budget increase in the FDA’s history. Margaret Hamburg, MD, was confirmed as the new FDA commissioner. Although it is too soon to tell, some experts believe that her new leadership team is likely to focus more on drug safety than on rapid new drug approvals. Recent legislation has expanded the agency's authority to require, rather than simply request, post-marketing safety studies from drug manufacturers. At the time of writing, a variety of new molecular entities had arrived on the market in 2009, but most were extensions of existing drug classes or “me-too” drugs. This article will focus on selected new drugs approved in 2009 that are likely to be of interest to the community-based practitioner including benzyl alcohol 5% (UlesfiaTM), dronedarone (Multaq®), febuxostat (Uloric®), pitavastatin (Livalo®), prasugrel (Effient®), saxagliptin (OnglyzaTM), tapentadol (NucyntaTM), iloperidone (FanaptTM), and asenapine (Saphris®). Each monograph summarizes the drug’s role in therapy, usual dose, precautions and drug interactions. Useful and practical patient counseling points are highlighted separately for easy access. Brief overviews for 8 additional new drugs are provided in a table. Other tables outline new formulations and new combination products you are likely to encounter in practice.