`
` NDA 022272/S-046
`
`
`
`
`
` Purdue Pharma LP
`
`
` One Stamford Forum
`
` 201 Tresser Blvd
` Stamford, CT 06901-3431
`
`
`Attention: Milad Khan, Mpharm, MS
`
`
` Director Regulatory Affairs
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
`
`
`
`
`
`
`
` Dear Mr. Khan:
`
`
`
`
` Please refer to your supplemental new drug application (sNDA) dated and received
` August 20, 2020, submitted under section 505(b) of the Federal Food, Drug, and
`
`
`
` Cosmetic Act (FDCA) for OxyContin (oxycodone hydrochloride) extended-release
`
`
` tablets.
`
`We also refer to our letter dated July 23, 2020, notifying you, under Section 505(o)(4) of
`the FDCA, of new safety information that we believe should be included in the labeling
`
` for opioid analgesic products used in the outpatient setting and products approved for
`medication-based treatment of opioid use disorder. This information pertains to the risk
`of fatal overdose to patients and their close contacts who may be at elevated risk of
`opioid overdose, and that increasing access to FDA-approved naloxone for some
`
`
` patients at elevated risk may help reduce the risk of fatal opioid overdose.
`
` This sNDA provides for revisions to the labeling for OxyContin, consistent with our July
`
`
` 23, 2020, letter.
`
`
` APPROVAL & LABELING
`
` We have completed our review of this application. It is approved, effective on the date of
`
`this letter, for use as recommended in the enclosed agreed-upon labeling, which
`
`contains minor editorial revisions.
`
` WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`
` 201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`
`
`
`
`
`
`Reference ID: 4756496
`
`
`
`
`
`
`
`
`
`
`
`
`
` NDA 022272/S-046
`
` Page 2
`
`
` 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
`
` FDA.gov.1 Content of labeling must be identical to the enclosed labeling, 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 SPL Standard for Content of Labeling Technical Qs and As.2
`
` The SPL will be accessible from publicly available labeling repositories.
`
` Also within 14 days, amend all pending supplemental applications that include 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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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).
`
` PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`
`
` final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`Prescription Drugs. 3
`
`
`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
`
` [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`
`
` Instructions for completing the form can be found at FDA.gov.5
`
`
`
`
`
`
`
`
` 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
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
`
` U.S. Food and Drug Administration
`
` Silver Spring, MD 20993
`
` www.fda.gov
`
`
`
`
`
`Reference ID: 4756496
`
`
`
`
`
` NDA 022272/S-046
`
` Page 3
`
`
`
`All promotional materials that include representations about your drug product must be
`promptly revised to be consistent with the labeling changes approved in this
`
`
` supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`in your promotional materials should include prominent disclosure of the important new
`
` safety information that appears in the revised labeling. Within 7 days of receipt of this
` letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`
`
`
` 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 LCDR Jessica Voqui, PharmD, MS, Safety Regulatory
`
` Project Manager, at (301) 796-2915.
`
`
`
`
`
`
`
`
`
`
`
`
` Sincerely,
`
` {See appended electronic signature page}
`
` LCDR Mark A. Liberatore, PharmD, RAC
`
` Deputy Director for Safety
`Division of Anesthesiology, Addiction Medicine,
`
` and Pain Medicine
` Office of Neuroscience
`
` Center for Drug Evaluation and Research
`
`
`
`
`
`
` ENCLOSURES:
`
`• Content of Labeling
`
`
`• Medication Guide
`
`
`
`
`
`
`
`
`
` U.S. Food and Drug Administration
`
` Silver Spring, MD 20993
`
` www.fda.gov
`
`Reference ID: 4756496
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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/
`------------------------------------------------------------
`
`MARK A LIBERATORE
`03/04/2021 09:07:38 AM
`
`Reference ID: 4756496
`
`(
`
`
`
`