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 : EC2
Submitter : Mr. David Lowe Date & Time: 06/27/2006 11:06:12
Organization : Mr. David Lowe
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I oppose this petition, Safety or Efficacy of Diastat.
BMS claims FDA approves of marketing in the attachment. Does FDA approve of an antidepressant being launched years in advance? Emsam is the name of the MAOI patch. "Tentatively approved" is what they mean. Misbrand Emsam. A pickle or wearing that new Daytrana patch will kill a kid. SEE ATTACHMENT, and remove that website. Misbrand Daytrana.
2006P-0209-EC2-Attach-1.PDF