`CENTER FOR DRUG EVALUATION AND RESEARCH
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`Approval Package for:
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`APPLICATION NUMBER:
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`22-272Orig1s014
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`OxyContin Tablets
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`Oxycodone hydrochloride controlled-release tablets
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`Purdue Pharma L.P.
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`April 16, 2013
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`Indicated for the management of moderate to severe
`pain when a continuous, around-the-clock opioid
`analgesic is needed for an extended period of time.
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`Trade Name:
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`Generic Name:
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`Sponsor:
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`Approval Date:
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`Indications:
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`CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`22-272Orig1s014
`
`CONTENTS
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`Reviews / Information Included in this NDA Review.
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`
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`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Medical Review(s)
`Chemistry Review(s)
`Environmental Assessment
`Pharmacology Review(s)
`Statistical Review(s)
`Microbiology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
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`X
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`X
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`X
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`X
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`X
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`X
`X
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`X
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`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`22-272Orig1s014
`APPROVAL LETTER
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 022272/S-014
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`
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`Purdue Pharma, L.P.
`One Stamford Forum
`Stamford, CT 06901-3431
`
`Attention: Beth Connelly
`
`Associate Director, Regulatory Affairs
`
`
`Dear Ms. Connelly:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated September 14, 2012,
`received September 14, 2012, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for OxyContin (Oxycodone Hydrochloride Controlled-Release) Tablets.
`
`We acknowledge receipt of your amendments dated September 20 and 28, 2012, and January 24,
`2013.
`
`This “Prior Approval” supplemental new drug application proposes addition of labeling language
`describing the results of pre- and post-marketing data from in vitro and in vivo abuse potential
`studies to the DRUG ABUSE AND DEPENDENDCE section of the Package Insert.
`
`We have completed our review of this supplemental application, as amended, and it is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
`
`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, Medication
`Guide), 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 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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`Reference ID: 3294108
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`
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`NDA 022272/S-014
`Page 2
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`
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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 includes 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 MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, 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
`
`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 Lisa E. Basham, Senior Regulatory Health Project Manager, at
`(301) 796-1175.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Bob A. Rappaport, M.D.
`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
`
`
`
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`Reference ID: 3294108
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`
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`BOB A RAPPAPORT
`04/16/2013
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`Reference ID: 3294108
`
`