Food and Drug Administration

Drug Safety and Risk Management Advisory Committee

and

Dermatologic and Ophthalmic Drugs Advisory Committee

February 26, 2004

FDA Briefing Information

February 4, 2004 Cover Letter From Dr. Jonca Bull, MD and Dr. Anne Trontell, MD, MPH, Food & Drug Administration (HTM) (PDF) (Word)

Table of Contents (HTM) (PDF) (Word)

Background of Isotretinoin Teratogenic Risk Management Plan (Isotretinoin Historical Summary) (HTM) (PDF) (Word)

October 6, 200 Letter From Dr. Janet Woodcock to Hoffmann-La Roche, Inc. Regarding the Need for Registry, Linkage of Pregnancy Status With Drug Dispensing (PDF)

October 31, 2001 Letter From Dr. Jonathan Wilkin to Hoffmann-LaRoche, Inc., Subject: Approval Letter for Accutane® (Isotretinoin) - NDA 18-662/S-044 (PDF)

November 8, 2002 Letter From Dr. Janet Woodcock to Ellen Flannery, Esq., Subject: Response to Citizen Petition, Dated February 25, 2002 Re: Procedures and Standards; AbbreviatedNew Drug Approvals (NDAs) (PDF)

January 29, 2004 Memorandum - Overview of the 1st Year of the Isotretinoin Risk Management Program (RMP), FDA (HTM) (PDF) (Word)

Overview of the First Year Evaluation of the Isotretinoin Risk Management Program, FDA (HTM) (PDF) (Word)

PID D030417, Drug: Isotretinoin, Topic: Pregnancy Exposures, Dated February 2, 2004, FDA (HTM) (PDF) (Word)

PID D030417, Drug: Isotretinoin, Topic: Isotretinoin Utilization, Dated February 2, 2004, FDA (HTM) (PDF) (Word)

PID D030417, Drug: Isotretinoin, Topic: Reveiw of Prescription Compliance Survey to Measure Compliance With Isotretinoin Qualification Stickers, Dated February 2, 2004, FDA (HTM) (PDF) (Word)

PID D030417, Drug: Isotretinoin, Topic: Reveiw of Prescription Compliance Survey Materials and Data With Interest in Compliance During the First Year of the System to Manage Accutane® Related Teratology (S.M.A.R.T)™ Program, Dated February 2, 2004, FDA (HTM) (PDF) (Word)

A Synopsis of the Elements of the S.T.E.P.S® (System for Thalidomide Education and Prescribing Safety) Program Dated February 2, 2004 (HTM) (PDF) (Word)

Thalomid PI (thalidomide) Capsules 50 mg, 100 mg, 200 mg, Generic Sponsors' Briefing Information (HTM) (PDF) (Word)

February 2, 2004 Cover Letter From Barr Laboratories, Inc. to the Advisory Committee Regarding Isotretinoin Capsules, USP, Amnesteem, ANDA 75-945-Mylan/Bertek; Sotret, ANDAs 76-041 and 76-503-Ranbaxy; and Claravis, ANDAs 76-135 and 76-356-Barr Laboratories (HTM) (PDF) (Word)

Addendum to the January 25, 2004 Roche Advisory Committee Briefing Document (HTM) (PDF) (Word)

Attachment 1- Mandatory Physician & All Female Patient Isotretinoin Registry (HTM) (PDF) (Word)

Attachment 2 - Mandatory Physician & All Female Patient Isotretinoin Registry, Hoffmann-La Roche Briefing Information (HTM) (PDF) (Word)

Accutane® (isotretinoin) Capsules, Hoffmann-La Roche, Inc. (PDF)