`NDA 208745/S-010
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`SUPPLEMENT APPROVAL
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` Salix Pharmaceuticals, Inc.
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` Attention: Libette Luce
` Senior Director, Global Regulatory Affairs
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` 400 Somerset Corporate Blvd
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` Bridgewater, NJ 08807
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`Dear Ms. Luce:
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`Please refer to your supplemental new drug application (sNDA) dated August 5, 2020,
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`received August 5, 2020, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Trulance (plecanatide) tablets.
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`This Prior Approval supplemental new drug application provides for updates to the
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`Prescribing Information in subsection 8.2 Lactation in the Use in Specific Populations
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`section to include results of a milk-only lactation study (PMR 3117-14).
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon labeling
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`with a minor editorial revision to add the revision date at the end of the Medication
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`Guide and reflected in the enclosed labeling.
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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
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Medication Guide), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed 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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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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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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`Reference ID: 4694216
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` NDA 208745/S-010
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` Page 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
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` 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
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`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
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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 Anum Shami, Regulatory Project Manager, at 301­
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`8377103 or email at anum.shami@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Joyce Korvick, M.D., M.P.H.
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`Deputy Director for Safety
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`Division of Gastroenterology (DG)
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`Office of Immunology and Inflammation (OII)
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`Center for Drug Evaluation and Research Center
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`for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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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: 4694216
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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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`JOYCE A KORVICK
`10/29/2020 03:06:02 PM
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`Reference ID: 4694216
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`(
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