US approval for abacavir

This article is more than 23 years old.

On December 18th, the American Food and Drug

Administration licensed Glaxo Wellcome’s nucleoside analogue RT inhibitor

abacavir (Ziagen™) for use in the treatment of HIV-infected adults.

Glossary

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

Abacavir is the fifteenth antiretroviral to be approved in the US.

Full, FDA-approved prescribing information and a patient information sheet on

the drug can be found online, including in PDF format, at

href="http://www.ziagen.com/">http://www.ziagen.com

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