January 23February 2, 2004, 2004


Ms. Shalini Jain

Advisors and Consultants Staff, HFD-21


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




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





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.




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)







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)

[1] Genpharm is the manufacturer and owner of the ANDA.