CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`022410Orig1s000
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`PROPRIETARY NAME REVIEW(S)
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`
`Date:
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`To:
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`Through:
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`From:
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`Subject:
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`Drug Name:
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`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
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`
`
`July 1, 2010
`
`Bob Rappaport, MD, Director
`Division of Anesthesia and Analgesia Products
`
`Denise Toyer, PharmD, Deputy Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Zachary Oleszczuk, PharmD, Acting Team Leader
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Proprietary Name Review
`Suboxone (Buprenorphine and Naloxone) Sublingual Film
`2 mg/0.5 mg and 8 mg/2 mg
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`Application Type/Number: NDA 022410
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`Applicant:
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`OSE RCM #:
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`Reckitt Benckiser Pharmaceuticals Inc.
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`2010-1000
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`*** This document contains proprietary and confidential information that should not be
`released to the public.***
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`1 BACKGROUND
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`1.1
`INTRODUCTION
`This re-assessment of the proprietary name responds to a notification that NDA 022410 may be approved
`within 90 days. The Division of Medication Error Prevention and Analysis (DMEPA) found the proposed
`proprietary name, Suboxone, acceptable in OSE Review #2009-165, dated July 8, 2009, OSE Review
`#2009-2342, dated February 18, 2010, and OSE Review #2010-492, dated April 20, 2010. The Division
`of Anesthesia and Analgesia Products did not have any concerns with the proposed name, Suboxone
`during the previous reviews, and the Division of Drug Marketing, Advertising and Communication
`(DDMAC) found the name acceptable from a promotional perspective on March 11, 2010.
`
`1.2 REGULATORY HISTORY
`, was found
`This is the third proprietary name submitted for this NDA. The first name
`unacceptable and this decision was communicated to the Applicant during a teleconference that was held
`on July 7 , 2009. DMEPA found the name
` unacceptable for this product because the word
`’ is incongruent with the final dosage form determined by ONDQA. This product does not meet the
`definition of a
` as defined by the CDER Data Standards Manual. DMEPA also provided comments
`on the container label and carton labeling on July 1, 2009.
`During the July 7, 2009, teleconference DMEPA informed the Applicant of our recommendation to
`manage this product and the currently marketed Suboxone sublingual tablets under the name ‘Suboxone’.
`The Applicant agreed to market both products under the same proprietary name, however the application
`was not approved during this review cycle and the Applicant received a complete response on
`August 8, 2009. Upon resubmission, the Applicant also submitted a request for a new proprietary name,
`Suboxone
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`
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`Thus, DMEPA found the proposed name
`unacceptable. However we maintained our recommendation from OSE Review #2009-165, that DMEPA
`believes that the both products could be managed under the same proprietary name 'Suboxone'.
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`2 METHODS AND MATERIALS
`Since the proposed proprietary name “Suboxone” has already been evaluated for this product, DMEPA
`staff search a standard set of databases and information sources (see Section 5) to identify names with
`orthographic and/or phonetic similarity to the proposed name that have been approved since the
`completion of the previous OSE proprietary name review. We used the same search criteria outlined in
`OSE Review #2009-165, dated July 8, 2009, OSE Review #2009-2342, dated February 18, 2010, and
`OSE Review #2010-492, dated April 20, 2010, for the proposed proprietary name, Suboxone.
`Since the last review of the proposed proprietary name, none of Suboxone’s product characteristics have
`been altered. Thus, we did not re-evaluate previous names of concern. Additionally, DMEPA searches
`the USAN stem list to determine if the name contains any USAN stems as of the last USAN updates.
`DMEPA bases the overall risk assessment on the findings of a Failure Mode and Effects Analysis
`(FMEA) of the proposed proprietary name, and focuses on the avoidance of medication errors.
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`2
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`3 RESULTS
`The searches of the databases did not yield any new names that were thought to look or sound similar to
`Suboxone and represent a potential source of drug name confusion. Additionally, DMEPA staff did not
`identify any United States Adopted Names (USAN) stems in the proposed proprietary name, as of
`June 15, 2010.
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`4 CONCLUSIONS AND RECOMMENDATIONS
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Suboxone, is not
`vulnerable to name confusion that could lead to medication errors, nor is the name considered
`promotional. Thus, the Division of Medication Error Prevention and Analysis (DMEPA) has no
`objection to the proprietary name, Suboxone, for this product at this time.
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days from
`the date of this review, the Division of Anesthesia and Analgesia Products should notify DMEPA because
`the proprietary name must be re-reviewed prior to the new approval date. We are willing to meet with the
`Division for further discussion, if needed. If you have further questions or need clarifications, please
`contact Abolade Adelou, OSE project manager, at 301-796-4264.
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`5 REFERENCES
`1. Oleszczuk, Z. OSE Review #2009-165: Proprietary Name Review for Suboxone
`2. Oleszczuk, Z. OSE Review #2009-2342: Proprietary Name Review for Suboxone
`February 18, 2010.
`3. Oleszczuk, Z. OSE Review #2008-1807: Label and Labeling Review for Suboxone
`July 1, 2009.
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`. July 8, 2009.
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`.
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`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`4.
`Drugs@FDA contains most of the drug products approved since 1939. The majority of labels, approval
`letters, reviews, and other information are available for drug products approved from 1998 to the present.
`Drugs@FDA contains official information about FDA approved brand name, generic drugs, therapeutic
`biological products, prescription and over-the-counter human drugs and discontinued drugs and
`“Chemical Type 6” approvals.
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`USAN Stems (http://www.ama-assn.org/ama/pub/category/4782.html)
`5.
`USAN Stems List contains all the recognized USAN stems.
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`Division of Medication Error Prevention and Analysis proprietary name requests
`6.
`This is a list of proposed and pending names that is generated by the Division of Medication Error
`Prevention and Analysis from the Access database/tracking system.
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`3
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`

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`Application
`Type/Number
`--------------------
`NDA-22410
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`RECKITT
`BENCKISER
`PHARMACEUTICA
`LS INC
`
`------------------------------------------
`SUBOXONE
`(BUPRENORPHINE/NALOXONE
`) sublingual film
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`ZACHARY A OLESZCZUK
`07/01/2010
`
`DENISE P TOYER
`07/01/2010
`
`