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` DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
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`Rockville, MD 20857
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`NDA 17-450/S-055
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`Johnson & Johnson Healthcare Products
`Attention: Renee L. Alliegro
`Manager, Regulatory Affairs
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`199 Grandview Road
`Skillman, New Jersey 08558-9418
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`Dear Ms. Alliegro:
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`Please refer to your supplemental new drug application dated April 21, 2008, received April 22, 2008,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Monistat 7
` (2% miconazole nitrate) vaginal cream.
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`We also acknowledge receipt of your submissions dated August 11, 15 and 18, 2008.
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`This supplemental new drug application provides for a new manufacturing site and associated labeling
`changes.
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`We have completed our review of this application. This application is approved, effective on the date
`of this letter, for use as recommended in the agreed upon labeling text.
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`The final printed labeling (FPL) must be identical to the submitted labeling (reusable applicator carton
`label, reusable applicator consumer information leaflet, reusable applicator cream tube label, and
`disposable applicator cream tube label submitted April 21, 2008, disposable applicator consumer
`information leaflet submitted August 15, 2008, and disposable applicator carton label submitted
`August 18, 2008), and must be formatted in accordance with the requirements of 21 CFR 201.66,
`where applicable.
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`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 this
`submission "FPL for approved supplement NDA 17-450/S-055.” Approval of this submission by
`FDA is not required before the labeling is used.
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`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
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`NDA 17-450/S-055
`Page 2
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`If you have any questions, call Mary Lewis, Regulatory Project Manager, at (301)796-0941.
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`Sincerely,
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` {See appended electronic signature page}
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`Joel Schiffenbauer, M.D.
`Deputy Director
`Division of Nonprescription Clinical Evaluation
`Office of Nonprescription Products
`Center for Drug Evaluation and Research
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`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
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`/s/
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`Joel Schiffenbauer
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`8/21/2008 02:57:00 PM
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