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` NDA 203752/S-012 and S-013
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`SUPPLEMENT APPROVAL
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` Noven Pharmaceuticals, Inc.
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` Attention: Fei Shao, Ph.D.
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` Manager, Regulatory Affairs
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` 100 Town Square Place, 5th Floor
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`Jersey City, NJ 07310
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`Dear Dr. Shao:
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`Please refer to your supplemental new drug applications (sNDAs) dated and received,
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`January 10, 2019, and June 28, 2019, and your amendments, submitted pursuant to
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`section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Minivelle
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`(estradiol transdermal system).
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`These Prior Approval sNDAs provide for revised labeling to comply with the Prior
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`Approval Supplement Request dated December 10, 2018, and to comply with the
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`Pregnancy and Lactation Labeling Final Rule (PLLR).
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`APPROVAL & LABELING
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`We have completed our review of these applications, as amended. They are approved,
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`effective on the date of this letter, for use as recommended in the enclosed agreed-
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`upon labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
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`Highlights of Prescribing Information. This waiver applies to all future supplements
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`containing revised labeling unless we notify you otherwise.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information, Patient Package Insert, and Instructions for Use), with the
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`addition of any labeling changes in pending “Changes Being Effected” (CBE)
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4874681
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` NDA 203752/S-012 and S-013
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` Page 2
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` supplements, as well as annual reportable changes not included in the enclosed
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`labeling
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
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`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`Word version. The marked-up copy should provide appropriate annotations, including
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`supplement number(s) and annual report date(s).
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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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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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`PROMOTIONAL MATERIALS
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` You may request advisory comments on proposed introductory advertising and
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` promotional labeling. For information about submitting promotional materials, see the
` final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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` Electronic Format-Promotional Labeling and Advertising Materials for Human
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` Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
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` https://www.fda.gov/media/128163/download.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4874681
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` NDA 203752/S-012 and S-013
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` Page 3
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` [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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` Instructions for completing the form can be found at FDA.gov.5
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`All promotional materials that include representations about your drug product must be
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`promptly revised to be consistent with the labeling changes approved in this
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`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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`in your promotional materials should include prominent disclosure of the important new
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`safety information that appears in the revised labeling. Within 7 days of receipt of this
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`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Kim Shiley, R.N., B.S.N., Regulatory Project Manager, at
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`(301) 796-2117.
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`Sincerely,
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`{See appended electronic signature page}
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`Christine P. Nguyen, M.D.
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`Director
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`Division of Urology, Obstetrics, and Gynecology
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`Office of Rare Diseases, Pediatrics, Urologic,
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`and Reproductive Medicine
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert or Medication Guide
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`o Instructions for Use
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4874681
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`Signature Page 1 of 1
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`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.
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`/s/
`------------------------------------------------------------
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`CHRISTINE P NGUYEN
`10/19/2021 12:30:38 PM
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`Reference ID: 4874681
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`(
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