`SERVICES
`
`
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 17-450/S-052
`
`Personal Products Company
`Attention: Ms. Terry Glass, Esq.
` Director, Regulatory Affairs
`199 Grandview Road
`Skillman, N.J 08558
`
`Dear Ms. Glass:
`
`Please refer to your supplemental new drug application dated January 18, 2002, received January 22,
`2002, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Monistat 7
`Cream Combination Pack.
`
`We also refer to your submission dated June 13, 2002.
`
`Your submission of June 13, 2002, constituted a complete response to our May 22, 2002 action letter.
`
`This supplemental new drug application provides for a revised labeling for a co-packaged product that
`includes seven prefilled applicators (each containing 100 mg of 2% miconazole nitrate cream) and a 9
`g tube of 2% miconazole nitrate cream for external use.
`
`We completed our review of this application as amended. This application is approved, effective on
`the date of this letter, for use as recommended in the agreed-upon labeling text.
`
`The final printed labeling (FPL) must be identical to the submitted labeling (consumer information
`leaflet and carton labels submitted June 13, 2002), and must be formatted in accordance with the
`requirements of 21 CFR 201.66.
`
`Please submit the FPL electronically 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, 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 "FPL for approved supplement NDA 17-450/S-052.” Approval of this
`submission by FDA is not required before the labeling is used.
`
`
`
`NDA 17-450/S-052
`Page 2
`
`In addition, please note the following recommendations:
`
`1. Delete “New!” in the phrase on the hanging flap which reads “New! With Cream for
`External Use”after 6 months of OTC marketing.
`
`2. In your Consumer Information Leaflet, insert a period after the second direction, first
`sentence, in the “Directions for using the Prefilled Applicators,” under the heading “How
`Should I Use MONISTAT 7 Vaginal Cream Combination Pack?”. This change can be
`submitted in the next annual report.
`
`We request that you submit one copy of the introductory promotional materials you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print to the Division of
`Over-the-Counter Drug Products.
`
`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, HF-2
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
`
`Please submit one market package of the drug product when it is available.
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
`
`If you have any questions, call Tia Frazier, Regulatory Project Manager, at (301) 827-2271.
`
`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
`8/7/02 11:10:17 AM
`
`
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