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`,.,. .........
`•-..:::::i~
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`ADMINISTRATION
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`
`NDA 203752/S-016
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`SUPPLEMENT APPROVAL
`
`
` Noven Pharmaceuticals, Inc.
` Attention: Fei Shao, Ph.D.
`
`
`
`
` Manager, Regulatory Affairs
`
` 100 Town Square Place, 5th Floor
`
`Jersey City, NJ 07310
`
`
`
`
`Dear Dr. Shao:
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`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
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`
`
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`April 1, 2021, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
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`
`
`Act (FDCA) for Minivelle (estradiol transdermal system).
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`
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`This “Changes Being Effected” sNDA provides for the following change in carton and
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`container labeling: addition of recommended dose frequency.
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`APPROVAL & LABELING
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`
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`We have completed our review of this application. It is approved, effective on the date of
`
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`this letter, for use as recommended in the enclosed agreed-upon labeling.
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`CARTON AND CONTAINER LABELING
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`
`Submit final printed carton and container labeling that are identical to the enclosed
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`carton and container labeling as soon as they are available, but no more than 30 days
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`after they are printed. Please submit these labeling electronically according to the
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`
`guidance for industry Providing Regulatory Submissions in Electronic Format — Certain
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`
`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Final Printed
`
`
`Carton and Container Labeling for approved NDA 203752/S-016.” Approval of this
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`
`submission by FDA is not required before the labeling is used.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`
`
`Reference ID: 4870563
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`
`
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`
`
`
` NDA 203752/S-016
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` Page 2
`
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
`
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` REPORTING REQUIREMENTS
`
`
`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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`If you have any questions, call Kim Shiley, Regulatory Project Manager, at (301)796-
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`2117.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Christine P. Nguyen, M.D.
`
`Director
`
`Division of Urology, Obstetrics, and Gynecology
`
`Office of Rare Diseases, Pediatrics, Urological,
`
`and Reproductive Medicine
`
`
`Center for Drug Evaluation and Research
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`
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`ENCLOSURE: Carton and Container Labeling
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`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
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`
`
`www.fda.gov
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`Reference ID: 4870563
`
`
`
`..
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`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/
`------------------------------------------------------------
`
`CHRISTINE P NGUYEN
`10/12/2021 09:11:21 AM
`
`Reference ID: 4870563
`
`(
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`(
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