November 14, 2001

 

Advisors and Consultants Staff

Food and Drug Administration

Center for Drug Evaluation and Research

Office of Regulatory Management

HFD-21, Room 1093

5630 Fishers Lane

Rockville, MD 20852-1734

SUBJECT: MATERIAL FOR THE ANTIVIRAL ADVISORY COMMITTEE MEETING DECEMBER 12, 2001

Dear Sir/Madam:

In response to the Agency letter dated October 30, 2001, Schering is providing for distribution to the Antiviral Advisory Committee 35 copies of the publications based on the results of the hepatitis pivotal clinical trial programs for REBETRONTM, PEG-INTRONTM and PEG-INTRONTM/REBETOLÒ . The publications included are:

Rebetron

PEG-Intron

 

 

 

 

PEG-Intron/Rebetol

As the material is copyrighted by the journal in which it was published, it is not being provided electronically.

Please contact Ms. Rachael Steiner (908-740-2565) or Dr. Penny Giles (908-740-2340) for additional information.

Sincerely,

Joseph F. Lamendola, Ph.D.
Vice President
U.S. Regulatory Affairs

 

 

 

 

 

 

 

 

 

 

 

RAS/eq