FDA Moves Deadline for Approval of Truvada as PrEP to September

Published: June 7, 2012

The following is an official communication from Gilead re: Truvada as PrEP.

The U.S. Food and Drug Administration (FDA) has advised Gilead that it has extended the target date for its priority review of Truvada for reducing the risk of HIV acquisition (also known as PrEP) by three months. This means that the agency will now make a decision on whether to approve Truvada for PrEP by September 14, 2012. The FDA has indicated that this extension relates to the agency’s standard administrative procedures for reviewing Gilead’s proposed Risk Evaluation and Mitigation Strategy (REMS) for Truvada as PrEP.  As was discussed at the FDA Advisory Committee Meeting last month, there are many components of a REMS, including a Medication Guide, educational training and an implementation system, all of which may require additional time for adequate FDA review. Gilead will continue to work closely and collaboratively with the FDA during this process, and [we] will keep you advised of any additional updates along the way. 

Full text of article available at link below –

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