New Drug Review 2011

Jack DeRuiter, PhD Professor; Pamela L. Holston, RPh, BS, BA


US Pharmacist 

In This Article

Abstract and Introduction


New molecular entities (NMEs), as defined by the FDA, are new drug products containing as their active ingredient a chemical substance marketed for the first time in the United States. The following descriptions of NMEs approved in 2010–2011 (Table 1) detail the basic clinical and pharmacologic profile of each new drug, as well as key precautions and warnings. Also included for each drug is a brief summary of selected pharmacokinetic, adverse-reaction, drug-interaction, and dosing data submitted to the FDA in support of the manufacturer's New Drug Application. This review is intended to be objective rather than evaluative in content. The information for each NME was obtained primarily from sources published prior to FDA approval. Experience clearly shows that many aspects of a new drug's therapeutic profile are not detected in premarketing studies and emerge after the drug is used in large numbers of patients. Studies have clearly demonstrated the appearance of "new" adverse reactions for many NMEs within 2 to 3 years of first becoming available. Some of these drugs may eventually acquire at least one black box warning for serious adverse reactions or are withdrawn from the market for safety reasons not recognized at the time of approval. Hence, while this review offers a starting point for learning about new drugs, it is essential that practitioners be aware of changes in a drug's therapeutic profile as reported by their own patients and in the pharmaceutical literature.


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