2003D-0206 - Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Application; Availability
FDA Comment Number : EC1
Submitter : Dr. Drucy Borowitz Date & Time: 06/10/2004 05:06:15
Organization : Women and Children's Hospital of Buffalo
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
Our article is misquoted (page 7, lines 283 and 284; reference on page 10 line 388). We recommend starting dose titration at 500-1000 lipase units/kg/meal. The maximum enzyme dose should be 2500 lipase units/kg/meal, NOT 6,000. It is very important to correct this error.