ISOTRETINOIN RISK MANAGEMENT PROGRAM Background Information Genpharm Inc. Mylan/Bertek Pharmaceuticals Inc. Barr Laboratories, Inc. Ranbaxy Pharmaceuticals Inc. For Presentation at FDA Advisory Committee Meeting Presenter: Frank R. Sisto February 26 and 27, 2004Vice President Corporate Regulatory Affairs Mylan Laboratories Inc.

APPROVED GENERIC ISOTRETINOIN CAPSULE PRODUCTS AND RISK MANAGEMENT PROGRAMS ProductCompanyRisk Management Program ANDA Approval Date Product Launch Date Amnesteem®Mylan/Bertek – Distributor Genpharm – Manufacturer S.P.I.R.I.T. 1 Nov 2002Dec Sotret®Ranbaxy Pharmaceuticals Inc. I.M.P.A.R.T. 2 Dec 2002 June 2003 March 2003 Claravis®Barr Laboratories, Inc.A.L.E.R.T. 3 April 2003 May System to Prevent Isotretinoin-Related Issues of Teratogenicity. 2 Isotretinoin Medication Program Alerting you to the Risks of Teratogenicity. 3 Adverse Event Learning and Education Regarding Teratogenicity.

NUMBER OF PREGNANCIES REPORTED BY GENERIC COMPANIES* SourceGenpharm Mylan/Bertek BarrRanbaxyTotal Slone Survey9009 Direct to Company91010 Total * As of February 5, 2004

SOURCE OF PREGNANCY REPORTS * Source Known Therapy Start Date Unknown Therapy Start Date Slone Survey9--- Direct to Company, Healthcare Professional 3--- Direct to Company, consumer or others 61 Total181 * As of February 5, 2004

TIMING OF EXPOSURE TO ISOTRETINOIN THERAPY RELATIVE TO PREGNANCY N = 19 Pregnant When Isotretinoin Started3 Pregnancy Occurred After Start Of Isotretinoin Treatment6 Pregnancy Occurred Within 30 Days Of Completion/Stopping Of Isotretinoin Treatment 5 Pregnancy Occurred Greater Than 30 Days After Completion/Stopping Of Isotretinoin Treatment 3 Unknown2

TIMING OF EXPOSURE TO ISOTRETINOIN VS. PREGNANCY OUTCOME PREGNANCY OUTCOME Delivery N Lost to Follow-Up N Ongoing N Spontaneous Abortion N Therapeutic Abortion N Unknown N Pregnant when Isotretinoin started 12 Pregnancy Occurred after Start of Isotretinoin Treatment 141 Pregnancy Occurred within 30 days of Completion /Stopping of Isotretinoin Treatment 311 Pregnancy Occurred Greater Than 30 Days After Completion/Stopping of Isotretinoin Treatment 21 Unknown11

PREGNANCY OUTCOME VS. OFFSPRING STATUS OFFSPRING STATUS Total Pregnancy Outcome Birth Defect N Lost to Follow-Up N Normal Baby N Other Disorder N Pregnancy Ongoing N Unknown NN % Delivery % Lost to Follow-Up % Pregnancy Ongoing % Spontaneous Abortion % Therapeutic Abortion % Unknown % Total %

AGE OF FEMALE PATIENTS FOR WHICH PREGNANCIES WERE REPORTED Age RangeN 0 – – – – – – Unknown3 Total19 Mean25.5 Median25 Range

ISOTRETINOIN PRESCRIPTION AUDIT [Conducted for Mylan/Bertek and Genpharm by Express Scripts, Inc. (ESI)] The Isotretinoin Prescription Audit Program was launched on March 10, 2003 and assessed isotretinoin prescriptions from April 1, 2002 through December 31, Objective of the program was to collect, analyze, and validate data pertaining to the dispensing of isotretinoin prescriptions under the current risk management program.

ISOTRETINOIN PRESCRIPTION AUDIT The primary endpoint for the audit was to determine the total number of stickered isotretinoin prescriptions in the total pool of evaluable ESI isotretinoin prescriptions. The secondary endpoint was to determine the total number of correctly completed isotretinoin stickered prescriptions in the total pool of evaluable ESI prescriptions containing yellow stickers.

ISOTRETINOIN PRESCRIPTION AUDIT 13,510 prescription-specific surveys* (representing 2,939 pharmacies) were returned and of these, 96.4% (13,021) reported that a yellow qualification sticker was present on the prescription (primary objective). The audit and validation process revealed that 96.3% of the responses were correctly answered in the survey. For the secondary objective the survey revealed that 97.6% of all prescription-specific surveys with a qualification sticker were filled out properly. The audit and validation process revealed that 95.9% of the responses were correctly answered in the survey. * Information based on review of actual prescriptions