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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 019516/S-043
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` NDA 022272/S-023
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`Food and Drug Administration
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` Silver Spring MD 20993
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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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` 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 Applications (sNDAs) dated April 17, 2014,
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`received April 23, 2014, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for MS CONTIN (morphine sulfate extended-release tablets) and
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`OXYCONTIN (oxycodone hydrochloride extended-release tablets).
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`These “Changes Being Effected” supplemental new drug applications provide for revised
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`immediate container labels for both drugs as well as revised carton labels and blister packs for
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`OXYCONTIN. The revisions include changing the dosage form from “controlled-release
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`tablets” to “extended-release tablets,” and changing the established name and dosage form
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`expression from “ (drug substance controlled-release) Tablets” to “ (drug substance extended-
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`release tablets)” to conform with FDA and USP current standards.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application and it is approved, effective on
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`the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your April 17, 2014, submissions containing final printed carton and container
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`labels for MS CONTIN and OXYCONTIN Tablets.
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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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`Reference ID: 3646951
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`Sincerely,
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`{See appended electronic signature page}
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`Sharon Hertz, MD
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`Acting Director
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`Division of Anesthesia, Analgesia,
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`and Addiction Products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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` NDA 019516/S-043
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` NDA 022272.S-023
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` Page 2
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` If you have any questions, call Lisa Basham, Senior Regulatory Health Project Manager, at (301)
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` 796-1175.
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`ENCLOSURE:
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`Carton and Container Labels
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`Reference ID: 3646951
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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
`10/22/2014
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`Reference ID: 3646951
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