`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
` NDA 021610/S-013
`
`
`
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`Endo Pharmaceuticals Inc.
`100 Endo Boulevard
`Chadds Ford, PA 19317
`
`
`Attention: Tara Chapman, Pharm.D.
`Director, Regulatory Affairs
`
`
`
`Dear Dr. Chapman:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated August 23, 2011,
`received August 23, 2011, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for OPANA ER (oxymorphone hydrochloride) Extended-Release Tablets,
`5, 7.5, 10, 15 20, 30, and 40 mg.
`
`We acknowledge receipt of your amendment dated January 9, 2012.
`
`This “Changes Being Effected” supplemental new drug application provides for the addition of a
`new subsection to the package insert, “6.2 Post-marketing Experience,” to include “Nervous
`system disorder: amnesia, convulsion, memory impairment.”
`
`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
`
`Please also refer to your sNDA (S-012), dated August 17, 2011, which provides for the
`Extended-Release/Long Acting (ER/LA) Opioid Class REMS. With that effort, the package
`inserts for all ER/LA opioids with a pain indication have been standardized and revised to
`current standards. The revisions derived from both sNDAS have been combined in the attached
`approved labeling.
`
`
`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert and text for the
`Medication Guide), with the addition of any labeling changes in pending “Changes Being
`
`
`
`Reference ID: 3155041
`
`

`

`
`
` NDA 021610/S-013
`Page 2
`
`
`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
`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications 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 MS Word format, that includes the changes approved in this
`supplemental application, as well as annual reportable changes and annotate each change. To
`facilitate review of your submission, 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).
`
`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 Lisa Basham, Senior Regulatory Health Project Manager, at (301)
`796-1175.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Bob A. Rappaport, M.D.
`
`Director
`
`Division of Anesthesia, Analgesia,
`and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
`Content of Labeling
`
`
`
`
`Reference ID: 3155041
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JUDITH A RACOOSIN on behalf of BOB A RAPPAPORT
`07/09/2012
`
`Reference ID: 3155041
`
`