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20-505/S-018 & 20-844/S015

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20-505/S-018 & 20-844/S015 CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 20-505/S-018 & 20-844/S015 Trade Name: Topamax Generic Name: topiramate Sponsor: Ortho-McNeil Pharmaceutical, Inc. Approval Date: June 29, 2005 Purpose: Provides for the use of topiramate as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 20-505/S-018 & 20-844/S015 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter X Other Action Letters X Labeling X Summary Review Officer/Employee List Office Director Memo Cross Discipline Team Leader Review Medical Review(s) X Chemistry Review(s) X Environmental Assessment X Pharmacology Review(s) X Statistical Review(s) X Microbiology Review(s) Clinical Pharmacology/Biopharmaceutics Review(s) X Other Reviews X Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review(s) Administrative/Correspondence Document(s) X CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 20-505/S-018 & 20-844/S015 APPROVAL LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 20-505/S-018 & NDA 20-844/S-015 NDA 20-505/S-026 & NDA 20-844/S-022 Ortho-McNeil Pharmaceutical, Inc. c/o Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Attention: Catherine M. Glamkowski Associate Director, Regulatory Affairs 920 Route 2020 South; P.O. Box 300 Raritan, New Jersey 08869-0602 Dear Ms. Glamkowski: Please refer to your supplemental new drug applications submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for the following: Application Drug Product Submitted Received on: Provides for: on: NDA 20-505/S-018 Topamax (topiramate) October 29, October 30, Use of topiramate as initial monotherapy in Tablets 2002 2002 patients 10 years of age and older with NDA 20-844/S-015 Topamax (topiramate partial onset or primary generalized tonic- capsules) Sprinkle clonic seizures. Capsules NDA 20-505/S-026 Topamax (topiramate) April 9, 2004 April 12, Information regarding drug interactions Tablets 2004 between topiramate and NDA 20-844/S-022 Topamax (topiramate hydrochlorothiazide and topiramate and capsules) Sprinkle pioglitazone. Capsules We also acknowledge receipt of your additional submissions to NDA 20-505/S-018 and NDA 20- 844/S-015 dated January 18, 2005, January 26, 2005, April 21, 2005, May 10, 2005, and May 17, 2005. Your submission of May 10, 2005 constituted a complete response to our January 19, 2005 action letter. We have completed our review of this application, as amended, and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the enclosed, agreed-upon labeling text. Accordingly, this application is approved, effective on the date of this letter. NDA 20-505/S-018/S-026 NDA 20-844/S-015/S-022 Page 2 Labeling The final printed labeling (FPL) must be identical to the enclosed approved labeling text (text for the package insert). Marketing these products with FPL that is not identical to the approved labeling text may render these products misbranded. Please submit an electronic version of the FPL according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15 of the copies on heavy-weight paper or similar material. For administrative purposes, designate these submissions "FPL for approved supplements NDA 20-505/S-018/S-026 and NDA 20-844/S-015/S- 022.” Approval of these submissions by FDA is not required before the labeling is used. Pediatrics All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are waiving the pediatric study requirement for initial monotherapy in patients with partial seizures or primary generalized tonic clonic seizures ages birth up to 2 years. We are deferring pediatric studies for initial monotherapy in patients with partial seizures or primary generalized tonic clonic seizures ages 2 years up to 10 years for this application. Your deferred pediatric studies required under section 2 of the Pediatric Research Equity Act (PREA) are considered required postmarketing study commitments. The status of this postmarketing study shall be reported annually according to 21 CFR 314.81. This commitment is listed below. 1. Deferred pediatric study(ies) under PREA for the treatment of initial monotherapy in pediatric patients with partial seizures or primary generalized tonic clonic seizures ages 2 years up to 10 years. Final Report Submission: June 30, 2010 Submit final study reports to this NDA. For administrative purposes, all submissions related to this/these pediatric postmarketing study commitment(s) must be clearly designated “Required Pediatric Study Commitments”. Postmarketing Study Commitments We remind you of your post-marketing study commitment in your submission dated May 27, 2004. This commitment is listed below, and we note that you submitted your draft protocol on November 24, 2004 as agreed. 1. A repeated-dose study in neonatal/juvenile rats to assess the effects of topiramate on growth and development NDA 20-505/S-018/S-026 NDA 20-844/S-015/S-022 Page 3 Submit draft protocol for review and discussion November 2004 Start range-finding study August 2005 Start definitive study November 2005 Total time post-sNDA approval for submission September 2006 of final report Submit clinical protocols to your IND for this product. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to this NDA. In addition, under 21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii), you should include a status summary of each commitment in your annual report to this NDA. The status summary should include expected summary completion and final report submission dates, any changes in plans since the last annual report, and, for clinical studies, number of patients entered into each study. All submissions, including supplements, relating to these postmarketing study commitments must be prominently labeled “Postmarketing Study Protocol”, “Postmarketing Study Final Report”, or “Postmarketing Study Correspondence.” Promotional Materials In addition, submit three copies of the introductory promotional materials that you propose to use for these products. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to this division and two copies of both the promotional materials and the package insert directly to: Division of Drug Marketing, Advertising, and Communications, HFD-42 Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Dear Healthcare Professional Letters If you issue a letter communicating important information about this drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to the following address: MEDWATCH, HFD-410 FDA 5600 Fishers Lane Rockville, MD 20857 Reporting Requirements We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). NDA 20-505/S-018/S-026 NDA 20-844/S-015/S-022 Page 4 If you have questions, call Jacqueline H. Ware, Pharm.D., Senior Regulatory Project Manager, at 301-594-2850. Sincerely, {See appended electronic signature page} Russell Katz, M.D. Director Division of Neuropharmacological Drug Products Office of Drug Evaluation I Center for Drug Evaluation and Research Enclosure --------------------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------------------- /s/ --------------------- Russell Katz 6/29/05 10:07:35 AM CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 20-505/S-018 & 20-844/S015 OTHER ACTION LETTER(s) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 20-505/S-018 NDA 20-844/S-015 Ortho-McNeil Pharmaceutical, Inc. c/o Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Attention: Catherine M. Glamkowski Associate Director, Regulatory Affairs 920 Route 2020 South; P.O. Box 300 Raritan, New Jersey 08869-0602 Dear Ms. Glamkowski: Please refer to your supplemental new drug applications dated October 29, 2002, received October 30, 2002, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Topamax (topiramate) Tablets and Topamax (topiramate capsules) Sprinkle Capsules. We acknowledge receipt of your additional submissions dated December 4, 2003, January 27, 2004, March 23, 2004, May 27, 2004, June 18, 2004, July 19, 2004, November 24, 2004, and January 6, 2005. Your submission of July 19, 2004 constituted a complete response to our November 26, 2003 action letter. These supplemental new drug applications provide for the use of topiramate as monotherapy in adults and children 6 years of age and older with
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