`
` NDA 203441/S-018
`
`
`
`SUPPLEMENT APPROVAL
`
`
`Shire-NPS Pharmaceuticals, Inc.
`Attention: Denzel Ngoma
`Senior Manager, Global Regulatory Affairs Development, GI
`
`40 Landsdowne Street
`Cambridge, MA 02139
`
`
`Dear Mr. Ngoma:
`
`Please refer to your supplemental new drug application (sNDA), dated and received on
`February 24, 2020, and your amendments, submitted under section 505(b) of the
`
`
`
`
`
`Federal Food, Drug, and Cosmetic Act (FD&C Act) for Gattex (teduglutide) for Injection.
`
`
`
`
`This Prior Approval sNDA provides updates to the human exposure margins in the
`Prescribing Information in Section 8.1 Pregnancy, 8.4 Pediatric Use, and 13.1
`Carcinogenesis, Mutagenesis, Impairment of Fertility, based upon data from animal
`toxicity studies.
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. 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.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, Medication Guide, and Instructions for Use), 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 The SPL will be
`accessible from publicly available labeling repositories. Also, within 14 days, amend all
`
`
`
`
` 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: 4738888
`
`
`
`NDA 203441/S-018
`Page 2
`
`
`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 (MS) 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 MS 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).
`
`Your product is a Part 3 combination product (21 CFR 3.2(e)); therefore, you must also
`comply with postmarketing safety reporting requirements for an approved combination
`product (21 CFR 4, Subpart B). Additional information on combination product
`postmarketing safety reporting is available at FDA.gov.3
`
`
` If you have any questions, contact Anum Shami, Regulatory Project Manager, at 301-
`
`837-7103 or at anum.shami@fda.hhs.gov.
`
`
`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`Joyce Korvick, M.D., M.P.H.
`Deputy Director for Safety
`Division of Gastroenterology
`Office of Immunology and Inflammation
`Center for Drug Evaluation and Research
`
`
`Enclosures:
`Content of Labeling:
` Prescribing Information
`Medication Guide
`Instructions for Use
`
`
`
`
`
`
` 3 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-
`
`reporting-combination-products
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4738888
`
`
`
`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
`01/29/2021 04:00:11 PM
`
`Reference ID: 4738888
`
`