2006P-0209 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
FDA Comment Number : EC10
Submitter : Mr. Dave Lowe Date & Time: 07/17/2006 12:07:56
Organization : Mr. Dave Lowe
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I oppose the petition. See attached. FDA approved labeling for the Lexapro website is included for review and regulatory action including injunctions. I cannot read that label. Is it approved for anxiety and depression? I couldn't find that. Please follow the law.
2006P-0209-EC10-Attach-1.PDF