Sustiva (efavirenz) label was recently revised

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Sustiva (efavirenz) label was recently revised

Information about FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.

The Sustiva (efavirenz) label was recently revised. The following sections in the Prescribing Information and Patient Counseling Information were update to include information about catatonia.

• WARNINGS AND PRECAUTIONS subsection 5.5 Psychiatric Symptoms
  
• ADVERSE REACTIONS subsection 6.2 Postmarketing Experience
  

The updated label will soon be available drugs@fda or DailyMed

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Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

 

For more information about the HIV Liaison Program visit the FDA Patient Network

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