`
`
`
`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:
`
`Refer to your supplemental new drug application (sNDA) dated and received
`December 4, 2023, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Minivielle (estradiol transdermal system)..
`
`We also refer to our letter dated November 6, 2023, notifying you, under Section
`505(o)(4) of the FDCA, of new safety information that we have determined should be
`included in the labeling for menopausal hormone therapy (MHT) products. This
`information pertains to the risk of breast cancer associated with the duration of use of
`MHT products.
`
`This supplemental new drug application provides for revisions to the labeling for
`Minivielle, consistent with our November 6, 2023, Safety Labeling Change Notification.
`
`
`APPROVAL & LABELING
`
`We have completed our review of this application. It is approved, effective on the date of
`this letter, for use as recommended in the enclosed agreed-upon labeling.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`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
`Prescribing Information, Patient Package Insert, and Instructions for Use), with the
`addition of any labeling changes in pending “Changes Being Effected” (CBE)
`supplements, as well as annual reportable changes not included in the enclosed
`labeling.
`
`
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`Reference ID: 5329164
`
`
`
`NDA 203752/S-22
`Page 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.2
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because none of these criteria apply to your application, you are exempt from this
`requirement.
`
`PROMOTIONAL MATERIALS
`
`All promotional materials that include representations about your drug product must be
`promptly revised to be consistent with the labeling changes approved in this
`supplement, including any new safety- related information [21 CFR 314.70(a)(4)]. The
`revisions in your promotional materials should include prominent disclosure of the
`important new safety-related information that appears in the revised labeling. Within 7
`days of receipt of this letter, submit your statement of intent to comply with 21 CFR
`314.70(a)(4).
`
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`
`
`
`
`2 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.
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5329164
`
`
`
`NDA 203752/S-22
`Page 3
`
`
`If you have any questions, call Meredith Hillig, MS, Safety Regulatory Project Manager,
`at (301) 796-1218.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Catherine Pilgrim-Grayson, M.D., M.P.H.
`Deputy Director for Safety Division of Urology,
`Obstetrics, and Gynecology
`Office of Rare Diseases, Pediatrics,
`Urologic, and Reproductive Products
`Center for Drug Evaluation and Research
`
`
`ENCLOSURES:
`• Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`Instructions for Use
`o
`
`
`
`
`
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5329164
`
`
`
`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/
`------------------------------------------------------------
`
`CATHERINE A PILGRIM-GRAYSON
`02/15/2024 10:14:04 AM
`
`Reference ID: 5329164
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
