CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`22-272Orig1s014
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`22-272Orig1s014
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`
`
` FDA CENTER FOR DRUG EVALUATION AND RESEARCH
`DIVISION OF ANESTHESIA, ANALGESIA, AND ADDICTION PRODUCTS
`HFD-170, Building 22, 10903 New Hampshire Ave. Silver Spring MD 20993
`Tel:(301)796-2280
`
`Memo to File
`
`NDA 22-272
`
`April 16, 2013
`
`
`
`Sharon Hertz, M.D.
`Deputy Director, DAAAP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`TO:
`
`DATE:
`
`
`FROM:
`
`
`
`RE:
`
`
`Several agency memoranda regarding reformulated OxyContin (OCR) refer to
`
`surveillance conducted by the Research Triangle Institute (RTI). RTI surveyed trends in the
`abuse of OxyContin before and after OCR was introduced into the market. RTI used two data
`sources: (1) the Client Treatment Study (CTS); and (2) the National Survey of Drug Use and
`Health (NSDUH).
`
`
`Research Triangle Institute OxyContin Surveillance Data
`
`
`These data, referred to collectively as the “RTI data,” were reviewed by FDA. An
`executive summary of the results was submitted to a public docket (FDA-2013P-0045). FDA
`considered the RTI data in making the relisting determination for original OxyContin (OC).
`However, FDA did not rely on the RTI data (nor was it necessary) to approve Supplement 014 to
`Purdue’s NDA 22-272.
`
`
`
`
`
`
`Reference ID: 3294232
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SHARON H HERTZ
`04/16/2013
`
`Reference ID: 3294232
`
`
`
`y‘l-WIQ‘W’
`
`g __/CDEPARTMENTOFHEALTHANDHUMANSERVICES
`
`
`\3,Q—‘h Food and Drug Administration
`
`Silver Spring, MD 20993
`
`ACKNOWLEDGEMENT —
`
`PRIOR APPROVAL SUPPLEMENT
`
`NDA 022272/8-014
`
`Purdue Pharma, L.P.
`One Stamford Forum
`
`Stamford, CT 06901—3431
`
`Attention: Beth Connelly
`Associate Director, Regulatory Affairs
`
`Dear Ms. Connelly:
`
`We have received your Supplemental New Drug Application (sNDA) submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act GDCA or the Act) for the following:
`
`NDA NUNIBER:
`
`022272
`
`SUPPLEMENT NUNIBER:
`
`S-014
`
`PRODUCT NAME:
`
`OxyContin (Oxycodone Hydrochloride Controlled—Release)
`Tablets
`
`DATE OF SUBMISSION:
`
`September 12, 2012
`
`DATE OF RECEIPT:
`
`September 14, 2012
`
`This supplemental application proposes the 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,
`W"
`
`Unless we notify you within 60 days of the receipt date that the application is not sufficiently
`complete to permit a substantive review, we will file the application on November 13, 2012, in
`accordance with 21 CFR 314.101(a).
`
`If the application is filed, the goal date will be March 14, 2013.
`
`If you have not already done so, promptly submit the content of labeling
`[21 CFR 314.50(l)(l)(i)] in structured product labeling (SPL) format as described at
`
`Reference ID: 31 94448
`
`
`
`NDA 022272/S-014
`Page 2
`
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Failure
`to submit the content of labeling in SPL format may result in a refusal-to-file action under
`21 CFR 314.101(d)(3).
`
`SUBMISSION REQUIREMENTS
`
`Cite the application number listed above at the top of the first page of all submissions to this
`application. Send all submissions, electronic or paper, including those sent by overnight mail or
`courier, to the following address:
`
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Anesthesia, Analgesia,
` and Addiction Products
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`
`
`All regulatory documents submitted in paper should be three-hole punched on the left side of the
`page and bound. The left margin should be at least three-fourths of an inch to assure text is not
`obscured in the fastened area. Standard paper size (8-1/2 by 11 inches) should be used; however,
`it may occasionally be necessary to use individual pages larger than standard paper size.
`Non-standard, large pages should be folded and mounted to allow the page to be opened for
`review without disassembling the jacket and refolded without damage when the volume is
`shelved. Shipping unbound documents may result in the loss of portions of the submission or an
`unnecessary delay in processing which could have an adverse impact on the review of the
`submission. For additional information, see
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/Drug
`MasterFilesDMFs/ucm073080.htm.
`
`If you have questions, call me at (301) 796-1175.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Lisa E. Basham, M.S.
`Senior Regulatory Health Project Manager
`Division of Anesthesia, Analgesia,
` and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`
`Reference ID: 3194448
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LISA E BASHAM
`09/25/2012
`
`Reference ID: 3194448
`
`
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