`
`
`
`SUPPLEMENT APPROVAL
`
`
`Salix Pharmaceuticals, Inc
`Attention: Libette Luce, MA
`Senior Director, Global Regulatory Affairs
`400 Somerset Corporate Blvd
`Bridgewater, NJ 08807
`
`
`Dear Dr. James:1
`
`Please refer to your supplemental new drug application (sNDA) dated October 20,
`2022, received, and your amendments, submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Apriso (mesalamine) extended-release
`capsules.
`
`We also refer to our letter dated September 26, 2022, 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 aminosalicyclic acid products and similar agents. This
`information pertains to the risk of nephrotoxicity.
`
`This supplemental new drug application provides for revisions to the labeling for Apriso
`(mesalamine), consistent with our September 26, 2022 letter.
`
`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.2 Content of labeling must be identical to the enclosed labeling (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.
`
`
`
`1 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.
`2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`Reference ID: 5077919
`
`
`
`NDA 22301-S21
`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.3
`
`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 Jacqueline LeeHoffman, Regulatory Project Manager, at
`(240) 402-8689.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Joyce Korvick, M.D., M.P.H.
`Deputy Director for Safety
`Division of Gastroenterology (DG)
`Office of Immunology and Inflammation (OII)
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
`• Content of Labeling
`o Prescribing Information
`
`
`
`
`3 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: 5077919
`
`
`
`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
`11/16/2022 10:58:11 AM
`
`Reference ID: 5077919
`
`
`
`
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