New Drug Review 2010

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

Disclosures

US Pharmacist 

In This Article

Abstract and Introduction

Introduction

New molecular entities (NMEs), as defined by the FDA, are 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 2009–2010 ( TABLE 1 ) detail the basic clinical and pharmacologic profiles for each new drug, as well as its pharmacokinetics, adverse reactions, drug interactions, and dosing data. Note that the information for each NME was obtained primarily from sources published prior to FDA approval; thus, it is essential that practitioners become aware of changes in a drug's therapeutic profile as reported by their own patients and in the pharmaceutical literature, such as the emergence of additional adverse reactions and black box warnings.

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