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` NDA 022301/S-015
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`SUPPLEMENT APPROVAL
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`Salix Pharmaceuticals, Inc.
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`Attention: Libette Luce, MA
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`Senior Director, Global Regulatory Affairs
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`400 Somerset Corporate Boulevard
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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 and received
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`October 16, 2019, and your amendments, submitted pursuant to section 505(b)(2) of
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`the Federal Food, Drug, and Cosmetic Act (FDCA) for Apriso (mesalamine) extended-
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`release capsules.
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`This Prior Approval supplemental new drug application provides for updates to the
`Prescribing Information (PI) to comply with the Pregnancy and Lactation Labeling Rule
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`(PLLR) and to the Warnings and Precautions section to add the risk of nephrolithiasis
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`with mesalamine. Other updates were made to the Warnings and Precautions and
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`Drug Interactions sections and addition of Use in Specific Populations, Renal
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`Impariment section to include mesalamine safety information for the drug class.
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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 minor editorial reivisions to update the revision date and reflected in the enclosed
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`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), with the addition of any labeling changes in pending “Changes
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`Being Effected” (CBE) supplements, as well as annual reportable changes not included
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`in the enclosed labeling.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4679440
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` NDA 022301/S-015
` Page 2
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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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`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
`Word version. The marked-up copy should provide appropriate annotations, including
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`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, contact Kelly Richards, Senior Regulatory Health Project
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`Manager, at (240) 402-4276 or email at kelly.richards@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
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`Office of Immunology and Inflammation
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`Center 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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` 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.
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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: 4679440
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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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
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`JOYCE A KORVICK
`10/01/2020 03:27:50 PM
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`Reference ID: 4679440
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`(
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