`NDA 208745/S-011
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
`
` Salix Pharmaceuticals, Inc.
` Attention: Mercy James, PhD, RAC
`
` Director, Global Regulatory Affairs
`
`
` 400 Somerset Corporate Blvd
`
` Bridgewater, NJ 08807
`
`
`
`Dear Dr. James:
`
`
`
`Please refer to your supplemental new drug application (sNDA) dated March 22, 2021,
`
`
`
`
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`
`for Trulance (plecanatide) tablets.
`
`
`
`
`
`
`This Changes Being Effected supplemental new drug application provides for updates
`
`
`to the Prescribing Information to section 6.2 Postmarketing Experience to include
`
`hypersensitivity reaction and vomiting.
`
`
`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 with a minor
`
`
`
`
`editorial revision to update the revision date and reflected in the enclosed
`
`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), 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.
`
`
`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
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
` 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.
`
`
`
`
`
`
`Reference ID: 4778584
`
`

`

` NDA 208745/S-011
`
` Page 2
`
`
`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 Microsoft Word
`
`
`
`
` 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
`
`
` 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).
`
`
` 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, call Andrew Dodson, PharmD, Regulatory Project Manager,
`
`
`
`at 301-796-8760.
`
`
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Joyce Korvick, MD, MPH
`
`
`Deputy Director for Safety
`
`Division of Gastroenterology
`
`Office of Immunology and Inflammation
`
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`
`ENCLOSURE(S):
`
`• Content of Labeling
`
`
`
`o Prescribing Information
`
`
`o Medication Guide
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 4778584
`
`

`

`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/
`------------------------------------------------------------
`
`JOYCE A KORVICK
`04/13/2021 05:16:26 PM
`
`Reference ID: 4778584
`
`(
`
`
`
`