`
`Public Health Service
`
`Food and Drug Administration
`Rockville MD 20857
`
`NDA 20-536/S-010
`
`
`Pharmacia and Upjohn Company
`Attention: Fred J. Frullo
` Associate Director, Regulatory Affairs
`100 Route 206 North
`Peapack, New Jersey 07977
`
`Dear Mr. Frullo:
`
`Please refer to your supplemental new drug application dated December 21, 2001, received December
`26, 2001, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Nicotrol
`Patch (15 mg nicotine transdermal system).
`
`We acknowledge receipt of your submissions dated April 23 and April 26, 2002.
`
`This supplemental new drug application provides revised labeling which incorporates the “Drug Facts”
`format.
`
`We have completed the review of this supplemental application, as amended, and it is approved
`effective on the date of this letter.
`
`The final printed labeling (FPL) must be identical to the submitted draft labeling (pouch labeling,
`Taking Action Handbook, Staying Smoke Free Handbook, and the Audiotape Script submitted April
`23, 2002, and 7 and 14 patch Starter Kit and Refill cartons and Information and Instructions Leaflet
`submitted April 26, 2002) and must be formatted in accordance with the requirements of 21 CFR
`201.66.
`
`Please submit the copies of final printed labeling (FPL) electronically according to the guidance for
`industry titled Providing Regulatory Submissions in Electronic Format - NDA (January 1999).
`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. Please individually mount ten of the copies on heavy-weight paper or
`similar material. For administrative purposes, this submission should be designated FPL for approved
`supplement NDA 20-536/S-010. Approval of this submission by FDA is not required before the
`labeling is used.
`
`
`
`NDA 20-536/S-010
`Page 2
`
`The following minor editorial revisions should be incorporated in the final printed labeling and
`submitted to the NDA with the final printed labeling for this supplement.
`
`1. Bold the word “more” in the statement, “For people who smoke more than 10 cigarettes a day”
`on the principal display panel (PDP).
`
`2. Revise the directions in diagram 5 of the Information and Instructions Leaflet to include the
`direction to fold the sticky ends of the used patch together, to be consistent with the Drug Facts
`labeling. This statement does not have to be bolded.
`
`3. Revise the directions in diagram 5 of the Information and Instructions Leaflet by combining
`bullets 7 and 8 under one bullet to read, “Stop using the patch at the end of 6 weeks. If you still
`feel the need to use the patch talk to your doctor.”
`
`If a letter communicating important information about this drug product (i.e., a Dear Health Care
`Professional letter) is issued to physicians and others responsible for patient care, we request that you
`submit a copy of the letter to this NDA and a copy to the following address:
`
`MEDWATCH, HF-2
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
`
`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, call Elaine Abraham, Project Manager, at (301) 827-2301.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Linda M. Katz, M.D., M.P.H.
`Deputy Director
`Division of Over-the-Counter Drug Products
`Office of Drug Evaluation V
`Center for Drug Evaluation and Research
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Linda Katz
`7/23/02 02:03:44 PM
`
`
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