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FDA Approves Truvada For PrEP With Bolstered Labeling But No Restricted Distribution

This article was originally published in The Pink Sheet Daily

Executive Summary

Concerned about impeding drug access for HIV treatment, the agency declined to restrict prescribing of Gilead’s antiretroviral for pre-exposure prophylaxis to documented evidence of a negative HIV test, although the label’s newly revised boxed warning highlights the need for confirmation of HIV-negative status.

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