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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`NDA 022272/S-005
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`Purdue Pharma L.P.
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`One Stamford Forum
`Stamford, CT 06901-3431
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`Attention: Beth Connelly
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`Associate Director, Regulatory Affairs
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`Dear Ms. Connelly:
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`Please refer to your supplemental new drug application dated and received June 11, 2010,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`OxyContin (Oxycodone Hydrochloride Controlled-Release) Tablets, 10 mg, 15 mg, 20 mg, 30
`mg, 40 mg, 60 mg, and 80 mg.
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`This “Prior Approval” supplemental new drug application provides for proposed modifications
`to the approved risk evaluation and mitigation strategy (REMS).
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`We have completed our review of this application and 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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` RISK EVALUATION AND MITIGATION STRATEGIES (REMS) REQUIREMENTS
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`The REMS for OxyContin (Oxycodone Hydrochloride Controlled-Release) Tablets was
`originally approved on April 5, 2010. The REMS consists of a Medication Guide, elements to
`assure safe use, and a timetable for the submission of assessments of the REMS. Your proposed
`modifications to the REMS are revisions to the Training Guide for Healthcare Providers that
`include adding “(oxycodone hydrochloride controlled-release)” to the headline page and
`indication, editorial corrections for the purpose of consistency with the approved final printed
`labeling, relocating the Table of Contents, renumbering references, and other minor
`typographical corrections and editorial revisions.
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`Your modified REMS, submitted on June 11, 2010, and appended to this letter, is approved. The
`timetable for submission of assessments of the REMS will remain the same as that approved on
`April 5, 2010.
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`There are no changes to the REMS assessment plan described in our April 5, 2010 letter.
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` NDA 022272/S-005
`Page 2
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`We remind you that the requirements for assessments of an approved REMS under section 505-
`1(g)(3) include, in section 505-1(g)(3)(A), an assessment of the extent to which the elements to
`assure safe use are meeting the goal or goals to mitigate a specific serious risk listed in the
`labeling of the drug, or whether the goal or goals or such elements should be modified.
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`Assessments of an approved REMS must also include, under section 505-1(g)(3)(B) and (C),
`information on the status of any postapproval study or clinical trial required under section 505(o)
`or otherwise undertaken to investigate a safety issue. With respect to any such postapproval
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`study, you must include the status of such study, including whether any difficulties completing
`the study have been encountered. With respect to any such postapproval clinical trial, you must
`include the status of such clinical trial, including whether enrollment has begun, the number of
`participants enrolled, the expected completion date, whether any difficulties completing the
`clinical trial have been encountered, and registration information with respect to requirements
`under subsections (i) and (j) of section 402 of the Public Health Service Act. You can satisfy
`these requirements in your REMS assessments by referring to relevant information included in
`the most recent annual report required under section 506B and 21 CFR 314.81(b)(2)(vii) and
`including any updates to the status information since the annual report was prepared. Failure to
`comply with the REMS assessments provisions in section 505-1(g) could result in enforcement
`action.
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`In addition to the assessments submitted according to the timetable included in the approved
`REMS, you must submit a REMS assessment and may propose a modification to the approved
`REMS when you submit a supplemental application for a new indication for use as described in
`section 505-1(g)(2)(A) of FDCA.
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`Prominently identify submissions containing REMS assessments or proposed modifications of
`the REMS with the following wording in bold capital letters at the top of the first page of the
`submission, as appropriate:
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`NDA 022272
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`REMS ASSESSMENT
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`NEW SUPPLEMENT FOR NDA 022272 -PRIOR APPROVAL SUPPLEMENT
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`PROPOSED REMS MODIFICATION
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`REMS ASSESSMENT
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`NEW SUPPLEMENT (NEW INDICATION FOR USE)
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`FOR NDA 022272
` REMS ASSESSMENT
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`PROPOSED REMS MODIFICATION (if included)
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`If you do not submit electronically, please send 5 copies of REMS-related submissions.
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` NDA 022272/S-005
`Page 3
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` LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA, to
`CDERMedWatchSafetyAlerts@fda.hhs.gov, and to the following address:
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`MedWatch
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`Food and Drug Administration
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`Suite 12B-05
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`5600 Fishers Lane
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`Rockville, MD 20857
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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 Lisa E. Basham, Senior Regulatory Health Project Manager, at
`(301) 796-1175.
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`Sincerely,
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`{See appended electronic signature page}
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`Larissa Lapteva, M.D., M.H.S.
`Deputy Director for Safety
`Division of Anesthesia and Analgesia Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`Enclosures:
`Package Insert
`REMS
`Medication Guide
`Dear Healthcare Professional Letter
`The Healthcare Provider Guide, “Prescribing OxyContin Tablets: A Training Guide For
`Healthcare Providers
`OxyContin Education Confirmation Form
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`Application
`Type/Number
`--------------------
`NDA-22272
`
`Submission
`Type/Number
`--------------------
`SUPPL-5
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`Submitter Name
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`Product Name
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`------------------------------------------
`--------------------
`PURDUE PHARMA OXYCONTIN
`INC
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LARISSA LAPTEVA
`06/29/2010
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`