throbber

`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 202107/S-006
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
`
`
` Corcept Therapeutics Incorporated
` Attention: Susan Rinne
`
` Vice President, Corporate Regulatory Affairs
`
` 149 Commonwealth Drive
`
` Menlo Park, CA 94025
`
`
`
`
`Dear Ms. Rinne:
`
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated April 22, 2016, received
`
`
`April 25, 2016, and your amendments, submitted pursuant to section 505(b)(2) of the Federal
`
`
`
`Food, Drug, and Cosmetic Act (FDCA) for Korlym (mifepristone) tablets, 300 mg.
`
`
`
`
`
`
`This Prior Approval supplemental new drug application provides for the addition of the term
`
`
`“angioedema” to the Postmarketing Experience subsection of Section 6, Adverse Reactions, of
`
`
`
`the package insert. Other minor editorial revisions were also proposed.
`
`
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application, as amended. It is approved,
`
`
`
`
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`
`
`text.
`
`
`WAIVER OF HIGHLIGHTS SECTION
`
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`
`
`
`
`
`201.57(d)(8) regarding the length of Highlights of prescribing information.
`
`
`
`
`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
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`
`
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`
`
`
`
`Medication Guide), 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.
`
`
`
`Reference ID: 4003895
`
`

`

`
`
` NDA 202107/S-006
`
` Page 2
`
`
`
`
` Information on submitting SPL files using eList may be found in the guidance for industry titled
` “SPL Standard for Content of Labeling Technical Qs and As at
`
`
`
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`
`
` Also within 14 days, amend all pending supplemental applications that include labeling changes
`
` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`
` with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`
`
`
`
`
` changes approved in this supplemental application, as well as annual reportable changes and
`
`
`
`
` annotate each change. To facilitate review of your submission, provide a 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 supplement number(s) and annual report
`date(s).
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`
`
`active ingredients, 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(s) 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
`
`
`
`
`
`
`
`
`You may request advisory comments on proposed introductory advertising and promotional
`
`
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`
`(3) the package insert(s) to:
`
`
`
`
`
`
`
`
`
`OPDP Regulatory Project Manager
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Office of Prescription Drug Promotion (OPDP)
`
`5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`
`
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
`
`
`
`Reference ID: 4003895
`
`

`

`
`
`
`
` NDA 202107/S-006
`
` Page 3
`
`
`
`
`
` You must submit final promotional materials and package insert(s), accompanied by a Form
` FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
`
`
`
`
`
` FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`
`more information about submission of promotional materials to the Office of Prescription Drug
`
`
`
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`If you have any questions, please call Jennifer Johnson, Regulatory Health Project Manager, at
`
`
`
`
`(301) 796-2194.
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Jennifer Rodriguez Pippins, M.D., M.P.H.
`
`Deputy Director for Safety
`
`
`Division of Metabolism and Endocrinology Products
`
`Office of Drug Evaluation II
`
`
`Center for Drug Evaluation and Research
`
`
`Package Insert and Medication Guide for Korlym (mifepristone) tablets
`
`
`
`
`
`
`ENCLOSURE:
`
`
`Reference ID: 4003895
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JENNIFER R PIPPINS
`10/25/2016
`
`Reference ID: 4003895
`
`(
`
`
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

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.

throbber

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.

Become a Member

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

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket