Sustiva (efavirenz) label was recently revised

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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