New Drug Review
New Drug Review
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 2012–2013 (Table 1) detail the basic clinical and pharmacologic profiles of each new drug, as well as key precautions and warnings. Also included is a brief summary of selected pharmacokinetic, adverse-reaction (AR), 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 demonstrates 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 demonstrated the appearance of "new" ARs for many NMEs within 2 to 3 years after they first become available. Some of these drugs may eventually acquire at least one Black Box Warning for serious ARs or are withdrawn from the market for safety reasons not recognized at the time of approval.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 in the pharmaceutical literature and by their own patients.
Abstract
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 2012–2013 (Table 1) detail the basic clinical and pharmacologic profiles of each new drug, as well as key precautions and warnings. Also included is a brief summary of selected pharmacokinetic, adverse-reaction (AR), 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 demonstrates 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 demonstrated the appearance of "new" ARs for many NMEs within 2 to 3 years after they first become available. Some of these drugs may eventually acquire at least one Black Box Warning for serious ARs 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 in the pharmaceutical literature and by their own patients.
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