New Drugs of 1999

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New Drugs of 1999

Abstract and Introduction

Abstract


Objective: To provide information regarding the most important properties of the new therapeutic agents marketed in 1999.
Data Sources: Published studies, drug information reference sources, and product labeling.
Data Synthesis: In 1999, 28 new therapeutic agents were marketed. The indications and information on dosage and administration for each new agent are reviewed, as are the most important pharmacokinetic properties, adverse events, drug interactions, and other precautions. Practical considerations for the use of the new agents are also discussed. Where possible, the properties of the new drugs are compared with those of older drugs marketed for the same indications.
Conclusion: A number of the new therapeutic agents marketed in 1999 have important advantages over older medications. An understanding of the properties of these agents is important for the pharmacist to effectively counsel patients about their use and to serve as a valuable source of information for other health care professionals regarding these drugs.

Introduction


In 1999 the Food and Drug Administration (FDA) approved 35 new molecular entities (NMEs), 33 of which are for therapeutic use and two are for diagnostic use. Twenty of these NMEs, as well as one new biological, were approved for therapeutic use and marketed in the United States in 1999. In addition, seven other NMEs that the FDA approved before 1999 were marketed during the year. Thus, a total of 28 therapeutic agents reached the U. S. market for the first time in 1999 (see ). Many of the 13 therapeutic agents approved in 1999 but not marketed before the end of the year ( Table 2 ) have become available in early 2000.

The 28 new therapeutic agents marketed in 1999 is a considerably smaller number than the more than 40 new drugs that were marketed in each of the previous 3 years. The number of NMEs approved and new therapeutic agents marketed each year during the 1990s is provided in Table 3 .

This review of the therapeutic agents first marketed in 1999 considers their most important properties and, when possible, compares them with other available agents with similar properties. This discussion of new drugs is not intended to be all-inclusive; when additional information is needed, more comprehensive references and the product literature should be consulted.

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