`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 022410/S-015
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
` Reckitt Benckiser Pharmaceuticals, Inc.
`
` 10710 Midlothian Turnpike, Suite 430
`
` Richmond, VA 23235
`
`
`
`Attention: Clorey Toombs
`
`
`
`
`Senior Manager, Regulatory Affairs
`
`
`Dear Ms. Toombs:
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated November 5, 2013,
`
`
`
`
`received November 5, 2013, submitted under section 505(b) of the Federal Food, Drug, and
`
`Cosmetic Act (FDCA) for Suboxone (buprenorphine and naloxone) sublingual film.
`
`
`
`
`
`
`
`This “Prior Approval” supplemental new drug application proposes changes to section
`
`
`
`
`17 (PATIENT COUNSELING INFORMATION) of the package insert to provide directions for
`
`
`disposal of unused Suboxone sublingual film.
`
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application. It is approved, effective on the
`
`
`
`
`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
`
`
`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 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 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.
`
`
`
`
`Reference ID: 3411281
`
`
`
`
`
`
`
` NDA 022410/S-015
`
` Page 2
`
`
`
`
` Also within 14 days, amend all pending supplemental applications that includes 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 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 Matt Sullivan, Senior Regulatory Project Manager, at
`
`
`
`(301) 796-1245.
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Judith A. Racoosin, M.D., M.P.H.
`
`Deputy Director for Safety
`
`
`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: 3411281
`
`
`
`---------------------------------------------------------------------------------------------------------
`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
`11/22/2013
`
`Reference ID: 3411281
`
`