EATG » FDA revises Sustiva label

FDA revises Sustiva label

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
News categories: EMA/FDA