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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 022272/S-039
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`Food and Drug Administration
`Silver Spring, MD 20993
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`SUPPLEMENT APPROVAL
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`Purdue Pharma, L.P.
`One Stamford Forum
`Stamford, CT 06901-3431
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`Attention: Richard J. Fanelli, PhD
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`Head of Regulatory Affairs
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`Dear Dr. Fanelli:
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`Please refer to your Supplemental New Drug Application (sNDA) dated March 7, 2018, received
`March 8, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for OXYCONTIN (oxycodone hydrochloride extended-release tablets).
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`This supplemental application proposes revisions to the DRUG ABUSE AND DEPENDENCE
`section of the Package insert. Under section 9.2 Abuse/ Risks Specific to Abuse of
`OXYCONTIN, language regarding increased risk of embolism and death, and thrombotic
`microangiopathy with parenteral drug abuse is added.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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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 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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. 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.
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`Reference ID: 4326201
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`NDA 022272/S-039
`Page 2
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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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 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).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Diana L. Walker, PhD, RAC, Senior Regulatory Health Project
`Manager, at (301) 796-4029.
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`Sincerely,
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`{See appended electronic signature page}
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`Sharon Hertz, MD
`Director
`Division of Anesthesia, Analgesia,
` and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling: Prescribing Information
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`Reference ID: 4326201
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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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`SHARON H HERTZ
`09/26/2018
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`Reference ID: 4326201
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