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 : EC9
Submitter : Mr. Dave Lowe Date & Time: 07/17/2006 12:07:26
Organization : Mr. Dave Lowe
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I oppose the petition. Public health issues need attention as well. The drug company still has a Paxil website. The entire label must be visible on that page, and understood by the consumer. See attachment. I can't see the boxed warning. I don't understand it. Remove the Paxil CR website.
2006P-0209-EC9-Attach-1.PDF