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`Food and Drug Administration
`Silver Spring MD 20993
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022272/S-006
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`Reference ID: 2863891
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` SUPPLEMENT APPROVAL
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`Purdue Pharma L.P.
`One Stamford Forum
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`Stamford, CT 06901-3431
`
`Attention: Beth Connelly
`Associate Directory, Regulatory Affairs
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`
`
`Dear Ms. Connelly:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated October 1, 2010,
`received October 5, 2010, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for OxyContin (Oxycodone Hydrochloride Controlled-Release) Tablets.
`
`We also acknowledge your risk evaluation and mitigation strategy (REMS) assessment and the
`proposed REMS modification dated October 6, 2010.
`
`This “Prior Approval” supplemental new drug application and the proposed REMS modification
`provide for changes to the DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS:
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`Postmarketing Experience, and PATIENT COUNSELING INFORMATION: Information
`for Patients and Caregivers sections of the Package Insert and Medication Guide to include
`language on proper administration of the product to minimize the risk of choking.
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`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.
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`We request that the labeling approved today be available on your website within 10 days of
`receipt of this letter.
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`CONTENT OF LABELING
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`
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert, Medication Guide) and include the
`labeling changes proposed in any pending “Changes Being Effected” (CBE) supplements.
`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
`
`

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` NDA 022272/S-006
`Page 2
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`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 for this NDA, including
`pending “Changes Being Effected” (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.
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`RISK EVALUATION AND MITIGATION STRATEGIES (REMS) REQUIREMENTS
`
`
`The REMS for OxyContin (oxycodone Hydrochloride Controlled-Release) Tablets was
`originally approved on April 5, 2010, and a REMS modification was approved on June 29, 2010.
`The REMS consists of a Medication Guide, elements to assure safe use, implementation system,
`and a timetable for submission of assessments of the REMS. Your proposed modification to the
`REMS consists of a revised Medication Guide with information about proper administration of
`the drug to minimize the risk of choking.
`
`Your proposed modified REMS, submitted on October 6, 2010, and appended to this letter, is
`approved. The timetable for submission of assessments of the REMS will remain the same as
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`that approved on April 5, 2010.
`
`
`There are no changes to the REMS assessment plan described in our April 5, 2010, letter.
`
`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)
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` or otherwise undertaken to investigate a safety issue. With respect to any such postapproval
`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
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`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 material or significant 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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`
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`Reference ID: 2863891
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`

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` NDA 022272/S-006
`Page 3
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`We remind you that 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.
`
`If you currently distribute or plan to distribute an authorized generic product under this NDA,
`you will also need to submit a REMS, REMS supporting document, and any required appended
`documents for that authorized generic, to this NDA. In other words, you must submit a complete
`proposed REMS that relates only to the authorized generic product. Review and approval of the
`REMS is required before you may market your product.
`
`Prominently identify the submission containing the REMS assessments or proposed
`modifications 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 REMS ASSESSMENT
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`NEW SUPPLEMENT FOR NDA 022272
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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
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`REMS ASSESSMENT
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`PROPOSED REMS MODIFICATION (if included)
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`
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`If you do not submit electronically, please send 5 copies of REMS-related submissions.
`
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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 the following
`address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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`Reference ID: 2863891
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`

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` NDA 022272/S-006
`Page 4
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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 Basham, M.S., Senior Regulatory Health Project Manager, at
`(301) 796-1175.
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`
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`Sincerely,
`
` {See appended electronic signature page}
`
`Sharon Hertz, M.D.
`Deputy Director
`Division of Anesthesia and Analgesia Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
`REMS
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`Reference ID: 2863891
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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/
`----------------------------------------------------
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`SHARON H HERTZ
`11/15/2010
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`Reference ID: 2863891
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