MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

 

 

 

DATE: October 2, 2007

 

TO: The Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee

 

FROM: FDA

SUBJECT: Errata to FDA Background document for the advisory committee meeting on October 18 & 19, 2007

 

 

The Division of Drug Risk Evaluation (DDRE) provides these corrections to the original background package submitted for the Joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee meeting scheduled for October 18 & 19, 2007.

 

 

The following items in the FDA Background volume 1, 2nd Safety Review need to be corrected. Deletions are indicated by strikethrough and corrections are in italics.

 

Page 3, first bullet, 3rd & 4th sub-bullets:

 

Page 53, seventh bullet, 3rd & 4th sub-bullets: