DRAFT
January 23February 2, 2004, 2004
Ms. Shalini Jain
Advisors and Consultants Staff, HFD-21
OEP/CDER
Food and Drug Administration
Room 1093
5630 Fishers Lane
Rockville, Maryland 20857
Ladies
and Gentlemen:
Re: NDA 18-662
- Accutane® (iIsotretinoin) Capsules, USP
Amnesteem,
ANDA 75-945 – Mylan/Bertek[1]
Sotret,
ANDAs 76-041 and 76-503 – Ranbaxy
Claravis,
ANDAs 76-135 and 76-356 – Barr Laboratories
General Correspondence: Addendum to the January 25, 2004 Roche Advisory
Committee Meeting Briefing Document
Reference is made to
the upcoming advisory meeting
of the Drug Safety and Risk Management Advisory Committee and the Dermatologic
and Ophthalmic Advisory Committee on February 26 and 27, 2004. This addendum is submitted on behalf of
the following generic companies who market or manufacture isotretinoin
capsules:
Mylan/ Bertek
Ranbaxy
Barr
Genpharm
This meeting has been
convened to discuss 1) discuss the
effectiveness of the isotretinoin risk management program for the prevention of
fetal exposures to Accutane and its generic equivalents, and 2) consider
whether changes to the isotretinoin risk management program would be
appropriate.
All the above Companies have
agreed to the content of the addendum. The Companies agree in principle with the Roche proposed risk
management program
submitted to the Agency on Jan. 25, 2004 with a few exceptions and
clarifications. The
purpose of this Addendum is to comment on the Roche proposal.
Please find enclosed 60 copies of the Addendum to the January 25, 2004 Roche Advisory Committee bBriefing pPackage to support this
meeting. This package is submitted by Roche on behalf
of Roche and the following Companies
who market or manufacture isotretinoin:
Hoffmann – La Roche
Mylan/ Bertek
Ranbaxy
Barr
Genpharm
The content of the package has been agreed to by all the
above Companies.
This submission also provides XX 1 diskettes. Each containings Microsoft Word
files of
the various portions of the documents that are available
electronically.
Also enclosed isare xx 1 CDdiskettes; each
containing xx Acrobat
files (pdf file), one for each complete volume. of the same documents.
Please do not hesitate to contact me if you have any
questions regarding this package.
Sincerely,
HOFFMANN-LA
ROCHE INC.Barr
Laboratories, Inc.
ChrisJoanna
Waughtine
Mundkur
Sr. Vice President Quality
and Regulatory Counsel
Telephone: (201) 930-3600
Fax: (201) 930- 3318
Regulatory Group Director
Drug
Regulatory Affairs
(973)
562-2566 (phone)
(973)
562-3700 (fax)
BCH/gb
Enclosures
HLR No.
2000-2175
cc: Dr. Steven Galson, (please check spellings and HFD
nos for all of these ) (1 desk copy)
Dr. Jonca
Bull (1 desk copy)
Dr Gary Buehler
(1 desk copy)
Dr. Paul Selligman (1 desk copy)
Dr. Jonathon Wilkin (1 desk copy)
Dr. Ann Trontell (1 desk copy)
Ms. Mary Jean Kozma-Fornaro (5 desk copies)
Mr. Patrick Guinn (5 desk copies)