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 : EC4
Submitter : Mr. Dave Lowe Date & Time: 06/27/2006 11:06:16
Organization : Mr. Dave Lowe
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I oppose the petition offering safety and efficacy, however raise an issue. Pfizer/Roeger's revised May 2005 label misbrands both flavors of Geodon. Geodon is both ziprasidone HCL and ziprasidone mesylate. Not safe for use, Geodon should be withdrawn, and any paper that left clinical trial data posted in live updates. ATTACHMENT
2006P-0209-EC4-Attach-1.PDF