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`ADMINISTRATION
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` NDA 022272/S-047
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`SUPPLEMENT APPROVAL
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` Purdue Pharma L.P.
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` One Stamford Forum
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` 201 Tresser Blvd.
` Stamford, CT 06901
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` Attention:
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` Jacqueline O. Nelson
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` Director Regulatory Affairs
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` Dear Ms. Nelson:
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` Please refer to your supplemental new drug application (sNDA) dated and received
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` April 30, 2021, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
` Act (FDCA) for OxyContin (oxycodone hydrochloride) extended release tablet.
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` This Prior Approval sNDA provides for changes to Section 13.1 Carcinogenesis,
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` Mutagenesis, Impairment of Fertility of the Prescribing Information, based on the final
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` study report for carcinogenicity study with oxycodone hydrochloride trihydrate in rats.
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` APPROVAL & LABELING
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` We have completed our review of this application, as amendmed. It is approved,
` effective on the date of this letter, for use as recommended in the enclosed agreed-
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` upon labeling.
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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
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` 201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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`Reference ID: 4880218
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` NDA 022272/S-047
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` Page 2
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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
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` content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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` the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information, and Medication Guide), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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
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` changes for this NDA, including CBE supplements for which FDA has not yet issued an
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` action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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` format, that includes the changes approved in this supplemental application, as well as
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` annual reportable changes. To facilitate review of your submission(s), provide a
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` highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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` Word version. The marked-up copy should provide appropriate annotations, including
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` supplement number(s) and annual report date(s).
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` PROMOTIONAL MATERIALS
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` You may request advisory comments on proposed introductory advertising and
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` promotional labeling. For information about submitting promotional materials, see the
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` final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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` Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`3 For the most recent version of a guidance, check the FDA guidance web page at
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`https://www.fda.gov/media/128163/download.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4880218
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` NDA 022272/S-047
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` Page 3
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` REPORTING REQUIREMENTS
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` We remind you that you must comply with reporting requirements for an approved NDA
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` (21 CFR 314.80 and 314.81).
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` If you have any questions, call Rachel Jang, PharmD, Regulatory Project Manager, at
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` 301-796-1288.
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` Sincerely,
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` {See appended electronic signature page}
`
` Rigoberto Roca, MD
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` Director
` Division of Anesthesiology, Addiction Medicine and
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` Pain Medicine
` Office of Neuroscience
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` Center for Drug Evaluation and Research
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` ENCLOSURE(S):
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` • Content of Labeling
` o Prescribing Information
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` o Medication Guide
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4880218
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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.
`--------------------------------------------------------------------------------------------
`/s/
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`RIGOBERTO A ROCA
`10/28/2021 02:55:48 PM
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`Reference ID: 4880218
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