CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICATION: NDA 20-771
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`CONTENTS
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`
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`Included
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`Pending
`Comgletion
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`Not
`Not
`Pregared Reguired
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`Agproval Letter
`Tenative Aggroval Letter
`Amgrovable Letter
`Final Printed Labeling
`Medical Review s}
`Chemist Review s
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`X
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`X
`X
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`X
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`EA/FONSI
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`Pharmacolo Review s
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`Statistical Reviewg s Q
`Microbiology Reviewg si
`Clinical Pharmacology
`Bio harmaceutics Review s
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`Bioeguivalence Reviewg s 2
`Administrative Documentgsi
`Corresgondence
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`X
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`X
`
`X
`
`X
`
`X
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`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1025 — Page 1
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1025 - Page 1
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`

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`CENTER FQ QR DRUG EVALUATION AND RESEARCH
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`Approval Package for:
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`Application Number: NDA 20-771
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`Trade Name: DETROL 1 & 2 MG TABLETS
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`Generic Name:(tolterodine L-tartrate)
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`Sponsor: Pharmacia & Upjohn Company
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`Approval Date: March 25, 1998
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`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1025 — Page 2
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1025 - Page 2
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`

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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`Appligation Num!1er:NDA 20-771
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`APPROVAL LETTER
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`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1025 — Page 3
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1025 - Page 3
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`NDA 2o-771
`
`HUMAN SERVICES
`
`
`
`Public Health Service
`rm and Drug Administration
`Rockvillo MD 20867
`
`Phannacia & Upjohn Co.
`Attention: Susan M. Mondabaugh, Ph.D.
`Director, U.S. Regulatory Affairs
`Unit 0635-298-113
`
`7000 Portage Road
`Kalamazoo, Michigan 49001
`
`Dear Dr. Mondabaugh:
`
`MAR 2 5 [998
`
`Please refer to your new drug application dated March 24, 1997, received March 25, 1997, submitted
`under section S05(b) of the Federal Food, Drug, and Cosmetic Act for DETROLW (tolterodine tartrate
`tablets).
`
`We acloiowledge receipt of your submissions dated April 14, 17, and 22, July 9 and 24, August 8, 12,
`and 29, September 12, October 31, November 18(2) and 24, and December 5, 23, and 31(2), 1997; and
`January 16, 27, 28, and 29(2), February 9, 11(2), 19, 24, and 25, a.nd March 4, 6, 11. 12, 13. 19, 20, 24
`and 25, 1998. The User Fee goal date for this application is March 25, 1998.
`
`This new drug application provides for the use of Detrol Tablets for the treatment of patients with an
`overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence.
`
`We have completed the review of this application, as amended, and have concluded that adequate
`information has been presented to demonstrate that the dmg product is safe and effective for use as
`recommended in the draft labeling. Accordingly, the application is approved effective on the date of this
`letter.
`-
`
`The final printed labeling (FPL) must be identical to the draft labeling in the submissions dated February
`25, 1998 (carton and container labels), March 6, 1998 (sample tray for blisters), and March 25, 1998
`(physician package insert). Marketing the product with FPL that is not identical to this drafi labeling
`may render the product misbranded and an unapproved new drug.
`
`1’
`
`Please submit 20 copies of the FPL as soon as it is available, in no case more than 30 days after it is
`printed. Please individually mount ten of the copies on heavy-weight paper or similar material. For
`administrative purposes, this submission should be designated "FINAL PRINTED LABELING" for
`approved NDA 20-771. Approval of this submission by FDA is not required before the labeling is used.
`
`'
`
`,/"
`
`We remind you of the Phase 4 commitment specified in your March 12, 1998, submission to conduct a
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1025 — Page 4
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1025 - Page 4
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`

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`NDA 20-771
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`Page 2
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`Protocol. data, and final reports should be submitted to your IND for this product and a copy of the cover
`letter sent to this NDA. In addition, under 21 CFR 3 14.8 l(b)(2)(vii), we request that you include a stunts
`summary of each commitment in your annual report to this application. The status summary should
`include the number of patients entered in the study, expected completion and submission dates, and any
`changes in plans since the last annual report. For administrative purposes, all submissions, including
`labeling supplements, relating to this Phase 4 commitment should be clearly designated "Phase 4
`Commitment. "
`
`-
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`In addition, please submit three copies of the introductory promotional material that you propose to use
`for this product. All proposed materials should be submitted in draft or mock-up form, not final print.
`Please submit one copy to the Division of Reproductive and Urologic Drug Products and two copies of
`both the promotional material and the package insert directly to:
`
`Food and Drug Administration
`Division of Drug Marketing, Advertising and Communications, HFD40
`5600 Fishers Lane
`V
`
`Rockville, Maryland 20857
`
`Validation of the regulatory methods has not been completed. At the present time, it is the policy of the
`Center not to withhold approval because the methods are being validated. Nevertheless, we expect your
`continued cooperation to resolve any problems that may be identified.
`
`Please submit one market package of the drug product when it is available.
`
`We remind you that you must comply with the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
`
`If you have any questions, please contact Alvis Dunson, Project Manager, at (301) 827-4260.
`
`Sincerely,
`
`James Bilstad. M.D.
`Director
`
`Office of Drug Evaluation 11
`Center for Drug Evaluation and Research
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`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1025 — Page 5
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1025 - Page 5