`
`
` NDA 17450/S-073
`
` NDA 20670/S-035
`
` NDA 20827/S-031
`
` NDA 21261/S-024
`
` NDA 21308/S-030
`
`
` SUPPLEMENT APPROVAL
`
`
`
`
` Medtech Products Inc.
`
` Attention: Mary Beth Fritz
`
` Sr. Vice President, Quality and Regulatory Affairs
`
`
` 660 White Plains Road
` Suite 250
`
`
` Tarrytown, NY 10591
`
`
` Dear Ms. Fritz:
`
`
`
`
`
` Please refer to your supplemental new drug applications (sNDAs) dated and received
` March 8, 2019, and your amendments, submitted under section 505(b) of the Federal
`
`
`
`
` Food, Drug, and Cosmetic Act (FDCA) for:
`
`
`
`
`
`
`
`• NDA 17450/S-073: Monistat 7 (miconazole nitrate) cream, 2%
`
`
`• NDA 20670/S-035: Monistat 3 Combination Pack (miconazole nitrate)
`
`
`
`
` suppository and cream, 200 mg and 2%
`• NDA 20827/S-031: Monistat 3 (miconazole nitrate) cream, 4%
`
`
`• NDA 21261/S-024: Monistat 3 Combination Pack (miconazole nitrate) cream,
`
`
` 4% and 2%
`• NDA 21308/S-030: Monistat 1 Combination Pack (miconazole nitrate)
`
`
`
` suppository and cream, 1,200 mg and 2%
`
`
`
`
` These “Prior Approval” supplemental new drug applications provide for the following:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`• Revision to the statement of identity to include increased font size, boldface
`
`
`
`
` type, and consistent nomenclature
`• Revision to the declaration of net quantity
`
`
`• Repositioning of the tamper-evident feature statement to the top panel of the
`
`
`
`
`
` outer carton
`• Multiple labeling deletions, revised layout changes, and updated distributor
`
`
` information
`• Addition of the statement “MAXIMUM STRENGTH OVULE®” to the right side
`
`
`
`
` of the principal display panel and back panel of the outer carton (NDA 21308
`
`
`
`
` only)
`
`Reference ID: 4552130
`
`

`

`
` NDA 17450/S-073
`
` NDA 20670/S-035
`
` NDA 20827/S-031
`
` NDA 21261/S-024
`
` NDA 21308/S-030
`
` Page 2
`
`
`
`• Addition of “[bullet] if you do not get complete relief ask a doctor before using
`
`
`
`
`
` another product” to the “When using this product” subheading under the
` Warnings heading (NDA 21308 only)
`
`
`
`
`
`
`
`
`
`
` In addition, NDA 017450/S-073 provides for the Monistat 7 (miconazole nitrate) cream,
` 2% (45g and 9g tubes + 7 disposable applicators) line extension.
`
`
`
`
`
` APPROVAL & LABELING
`
` We have completed our review of these applications, as amended. They are approved,
`
`
`
`
`
`
`
` effective on the date of this letter, for use as recommended in the enclosed agreed-
`
`upon labeling.
`
` LABELING
`
` Submit final printed labeling (FPL), as soon as they are available, but no more than 30
`
`
`
`
`
` days after they are printed. The FPL must be in the “Drug Facts” format (21 CFR
` 201.66), where applicable, and identical to the following:
`
`
`
`
`
` NDA 17450/S-073:
`
`1. Monistat 7 (miconazole nitrate) cream, 2% (45g tube + 1 reusable applicator)
`
`
`
` outer carton labeling submitted on January 10, 2020
`
`2. Monistat 7 (miconazole nitrate) cream, 2% (45g tube + 7 disposable
`
`
`
`
` applicators) outer carton labeling submitted on January 10, 2020
`
`3. Monistat 7 (miconazole nitrate) cream, 2% (45g and 9g tubes + 7 disposable
`
`
`
`
` applicators) outer carton labeling submitted on December 9, 2019
`
`
`
`
`
` NDA 20670/S-035:
`
`4. Monistat 3 Combination Pack (miconazole nitrate) vaginal inserts and cream,
`
`
`
` 200 mg and 2% outer carton labeling submitted on January 10, 2020
`
`
`
`5. Monistat 3 Combination Pack (miconazole nitrate) suppository and cream,
`
`
`
`
`
` 200 mg and 2% outer carton labeling submitted on December 9, 2019
`
`
` NDA 20827/S-031:
`
`6. Monistat 3 (miconazole nitrate) cream, 4% outer carton labeling submitted on
`
`
`
`
`
` December 9, 2019
`
`
`
`
`
`
`
` U.S. Food and Drug Administration
`
`
`
` Silver Spring, MD 20993
`
` www.fda.gov
`
`
`
`Reference ID: 4552130
`
`

`

`
` NDA 17450/S-073
`
` NDA 20670/S-035
`
` NDA 20827/S-031
`
` NDA 21261/S-024
`
` NDA 21308/S-030
`
` Page 3
`
`
` NDA 21261/S-024:
`
`7. Monistat 3 Combination Pack (miconazole nitrate) cream, 4% and 2% outer
`
`
`
`
` carton labeling submitted on December 9, 2019
`
`
`
` NDA 21308/S-030:
`
`
` 8. Monistat 1 Combination Pack (miconazole nitrate) suppository and cream,
`
`
`
`
` 1,200 mg and 2% outer carton labeling submitted on December 9, 2019
`
`
`
`
`
`
`
`
` The FPL should be submitted electronically according to the guidance for industry
`
`
`
`
`Providing Regulatory Submissions in Electronic Format — Certain Human
`
`
`
`Pharmaceutical Product Applications and Related Submissions Using the eCTD
` Specifications.1 For administrative purposes, designate the submissions “Final Printed
`
`
`
`
`
`
` Labeling for approved NDA 17450/S-073”, “Final Printed Labeling for approved
` NDA 20670/S-035”, “Final Printed Labeling for approved NDA 20827/S-031”, “Final
`
`
`
`
`
` Printed Labeling for approved NDA 21261/S-024”, and “Final Printed Labeling for
` approved NDA 21308/S-030.” Approval of these submissions by FDA is not required
`
`
`
`
`
`
` before the labeling is used.
`
`
` DRUG REGISTRATION AND LISTING
`
`
`
` All drug establishment registration and drug listing information is to be submitted to FDA
`
` electronically, via the FDA automated system for processing structured product labeling
`
`
` (SPL) files (eLIST). At the time that you submit your final printed labeling (FPL), the
`
`
`
` content of labeling (Drug Facts) should be submitted in SPL format as described at
`
`
`
` FDA.gov.2 Information on submitting SPL files using eLIST may be found in the
`
`
`
`
`
`
`
` guidance for industry SPL Standard for Content of Labeling Technical Qs and As. In
`
`
`
` addition, representative container or carton labeling, whichever includes Drug Facts,
` (where differences exist only in the quantity of contents statement) should be submitted
`
`
` as a JPG file.
`
` REPORTING REQUIREMENTS
`
`
` We remind you that you must comply with reporting requirements for an approved NDA
`
` (21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`
`
`
`
`
`
` 1 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
` 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
` U.S. Food and Drug Administration
`
`
`
` Silver Spring, MD 20993
`
` www.fda.gov
`
`
`
`
`
`
`
`Reference ID: 4552130
`
`

`

`
` NDA 17450/S-073
`
` NDA 20670/S-035
`
` NDA 20827/S-031
`
` NDA 21261/S-024
`
` NDA 21308/S-030
`
` Page 4
`
`
` If you have any questions, call Helen Lee, Regulatory Project Manager,
`
` at 301-796-6848.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Sincerely,
`
` {See appended electronic signature page}
`
` Karen Murry Mahoney, MD, FACE
`
`
`
` Acting Deputy Director, Office of Nonprescription Drugs
` Acting Deputy Director, Division of Nonprescription Drugs II
`
`
`
` Center for Drug Evaluation and Research
`
`
` ENCLOSURE(S):
`
`• Carton Labeling
`
`
`
`
`
`
` U.S. Food and Drug Administration
`
`
`
` Silver Spring, MD 20993
`
` www.fda.gov
`
`
`
`Reference ID: 4552130
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`KAREN M MAHONEY
`01/28/2020 04:42:50 PM
`
`Reference ID: 4552130
`
`(
`
`
`
`