CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
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`202570Orig1s000
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`PROPRIETARY NAME REVIEW(S)
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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
`Office of Medication Error Prevention and Risk Management
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`
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`Date:
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`August 3, 2011
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`Application Type/Number: NDA 202570
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`Through:
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`From:
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`Subject:
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`Drug Name(s):
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`Applicant:
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`OSE RCM #:
`
`Todd Bridges R.Ph., Team Leader
`Carol Holquist, R.Ph., Director
`Division of Medication Error Prevention and Analysis
`
`Kevin Wright, Pharm.D., Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`Proprietary Name Review
`
`Xalkori (crizotinib) capsules
`200 mg and 250 mg
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`Pfizer Pharmaceuticals, Inc.
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`2011-2590
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`*** This document contains proprietary and confidential information that should not be
`released to the public.***
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`Reference ID: 2983197
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`1
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Xalkori, responds to the anticipated approval of NDA
`202570 within 90 days from the date of this review. In OSE Review #2011-1168 dated June 2011, the
`proprietary name, Xalkori, was found acceptable.
`
`2 METHODS
`For the proposed proprietary name, Xalkori, DMEPA safety evaluators search a standard set of databases and
`information sources (see section 5) to identify names with orthographic and phonetic similarity to the proposed
`name that have been approved since the completion of the previous OSE proprietary name review. The safety
`evaluator did not evaluate the names identified in the previous reviews because none of the product
`characteristics have been altered since the time of the last review. For this re-assessment, we used the same
`search criteria outlined in our previous OSE reviews.
`Additionally, DMEPA searched 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.
`DDMAC re-assessed the proposed name on April 14, 2011.
`
`3 RESULTS
`The safety evaluator’s search of the databases listed in Section 5 did not identify any additional names
`orthographically, phonetically, or having shared characteristics to Xalkori. Additionally, DMEPA staff did not
`identify any United States Adopted Names (USAN) stems in the proposed proprietary name, as of August 1,
`2011.
`Additionally, DDMAC had no concerns regarding the proposed name from a promotional perspective.
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`4 CONCLUSIONS
`The Proprietary Name Risk Assessment identified that the proposed name, Xalkori, is not vulnerable to name
`confusion that could lead to medication errors nor is it considered promotional. Thus, the Division of
`Medication Error Prevention and Analysis (DMEPA) has no objection to the proprietary name, Xalkori, for this
`product.
`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 Drug Oncology Products should notify DMEPA because the proprietary
`name must be re-reviewed prior to the new approval date.
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`________________________
`***This document contains proprietary and confidential information that should not be released to the public.***
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`Reference ID: 2983197
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`2
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`5 REFERENCES
`1.
`Baugh, D; OSE review #2010-1790, Proprietary Name Review of Xalkori (Crizotinib), February 8,
`2011.
`2.
`Baught, D; OSE review #2011-1168 Proprietary Name Review of Xalkori (Crizotinib), June 27, 2011.
`3. Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`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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`4.
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`5.
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`USAN Stems (http://www.ama-assn.org/ama/pub/category/4782.html)
`USAN Stems List contains all the recognized USAN stems.
`Division of Medication Error Prevention and Analysis proprietary name requests
`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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`***This document contains proprietary and confidential information that should not be released to the public.***
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`Reference ID: 2983197
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`3
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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/
`----------------------------------------------------
`
`KEVIN S WRIGHT
`08/03/2011
`
`TODD D BRIDGES
`08/03/2011
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`CAROL A HOLQUIST
`08/03/2011
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`Reference ID: 2983197
`
`

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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
`
`Through:
`
`From:
`
`Date:
`Application Type/Number:
`To:
`
`June 27, 2011
`NDA 202570
`Robert Justice, MD, Director
`Division of Drug Oncology Products
`Todd Bridges, RPh, Team Leader
`Kellie Taylor, PharmD, Associate Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`Denise V. Baugh, PharmD, BCPS, Safety Evaluator
`Division of Medication Error Prevention and Analysis (DMEPA)
`Proprietary Name Reconsideration Request Review
`Xalkori (Crizotinib) Capsules
`200 mg and 250 mg
`Applicant:
`Pfizer Pharmaceuticals, Inc.
`OSE RCM #:
`2011-1168
`**This document contains proprietary drug use data obtained by FDA under contract. The drug
`use data/information cannot be released to the public/non-FDA personnel without contractor
`approval obtained through the FDA/CDER Office of Surveillance and Epidemiology.**
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`Subject:
`Drug Name and Strengths:
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`Reference ID: 2965972
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`EXECUTIVE SUMMARY
`This review summarizes the Division of Medication Error Prevention and Analysis’ (DMEPA)
`evaluation of the request for reconsideration of the proposed proprietary name, Xalkori. DMEPA
`concluded in OSE Review 2010-1790, dated February 8, 2011, that the name is unacceptable due
`to orthographic and/or phonetic similarity and shared product characteristics to the marketed
`names, Voltaren and Valturna, as well as with
` a proposed proprietary name for a
`pending application. The original submission provided for a
` product strength for Xalkori.
`In their request for reconsideration of the name, the Applicant states that they will no longer
`pursue this strength and therefore, there is less potential for confusion between Xalkori and these
`names.
`In their response, the Applicant submitted an independent safety analysis conducted by
` in support of the proposed proprietary name, Xalkori. Upon analysis of the information
`provided by the Applicant, we believe elimination of the
` strength helps to minimize the
`possibility of confusion between Xalkori vs. Voltaren and Xalkori vs. Valturna. We also
`determined that the proposed proprietary name for a pending application,
` is no longer
`a potential source of confusion with the name, Xalkori.
`Therefore, we have reconsidered our original decision and now have no objections to the use of
`the proprietary name, Xalkori, for this product at this time.
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`
`
`1.1
`INTRODUCTION
`This review responds to a March 31, 2011, request from Pfizer Pharmaceuticals, Inc. to
`reconsider the proposed proprietary name, Xalkori, for NDA 202570.
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`1.2 REGULATORY HISTORY
`The Division of Medication Error Prevention and Analysis (DMEPA) found the proposed name,
`Xalkori, unacceptable in OSE Review 2010-1790 based on orthographic and/or phonetic
`similarity and shared product characteristics to the marketed names, Voltaren and Valturna, as
`well as well as with
` a proposed proprietary name for a pending application. The
`Applicant was notified of our decision in writing via letter dated February 8, 2011. The
`Applicant submitted a request for reconsideration of the proposed proprietary name, Xalkori, on
`March 31, 2011.
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`2 METHODS AND MATERIALS
`DMEPA reviewed Pfizer Pharmaceutical, Inc’s request for reconsideration, which includes an
`external study completed by
` in support of the use of the proprietary name,
`Xalkori
` as well as our initial review of the proposed proprietary name,
`Xalkori (OSE Review 2010-1790). We also evaluated the status of the proposed proprietary
`name for a pending application,
` to determine if the name is still a potential source of
`confusion with the name, Xalkori.
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`Reference ID: 2965972
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` 3
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` RESULTS AND DISCUSSION
`The external study provides information in support of the use of Xalkori as a safe and acceptable
`proprietary name candidate for crizotinib.
`In their request to re-evaluate this name, the Applicant proposes that the decision to withdraw the
` strength for Xalkori from the application changes the vulnerability of Xalkori to
`confusion with the marketed names, Voltaren and Valturna by reducing the dosing strength
`similarity.
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`3.1 LOOK-ALIKE SIMILARITY OF XALKORI AND VOLTAREN
` dose of Xalkori could
`In our initial review of the proposed name, we determined that the
`be achieved with the available product strengths of Voltaren (or generic equivalent). Considering
`the Applicant’s commitment not to pursue the
` product strength for Xalkori, we completed
`a preliminary drug usage data profile to determine if the remaining 200 mg and 250 mg doses of
`Xalkori (which are achievable with the available product strengths of generic Voltaren) may
`contribute to confusion between the names Xalkori and Voltaren. The drug usage information
`retrieved indicates that prescribers are not ordering daily doses of Voltaren above 200 mg (SDI's
`Vector Alpha database). Therefore, we are in agreement with the Applicant that a prescription
`for Xalkori 200 mg or 250 mg twice daily is unlikely to be misinterpreted as Voltaren 200 mg or
`250 mg twice daily since this exceeds the 200 mg maximum recommended daily dose for
`Voltaren by 200 mg or more.
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`3.2 LOOK-ALIKE SIMILARITY OF XALKORI AND VALTURNA
`
`In our previous analysis of the name Xalkori,
` risk of
` Xalkori
` Valturna (150 mg/160 mg) and
` product strength
`proprietary name confusion between Xalkori and Valturna. Since the
`will no longer be pursued by the Applicant, our concern regarding confusion between this name
`pair is minimized.
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`3.3 LOOK-ALIKE SIMILARITY OF XALKORI AND PROPOSED PROPRIETARY NAME
`PENDING IN THE AGENCY
`), was found
` the proposed proprietary name for a pending application (NDA
`to be orthographically and phonetically similar to the proposed name, Xalkori. Subsequently, the
`proposed name,
` was found to be unacceptable by DMEPA because of orthographic
`similarity and shared product characteristics with the marketed product, Zolinza. Additionally,
`the current application status for the
` product is “refuse to file”. The Applicant has
`expressed their intentions to resubmit the application in the fall of 2011, whereas the action date
`for the Xalkori application is August 29, 2011.
`Therefore, this name is no longer considered to be a name with potential for confusion with
`Xalkori.
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`Reference ID: 2965972
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` 4
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` CONCLUSIONS AND RECOMMENDATIONS
`Our analysis of the information provided by the Applicant in support of reconsideration of the
` strength from the
`proposed proprietary name, Xalkori, determined the elimination of the
`application decreases the likelihood of confusion between Xalkori and the marketed names
`Voltaren and Valturna. Additionally, the proposed proprietary name for a pending application,
` is no longer considered to be a name with potential for confusion with Xalkori.
`Therefore, we have reconsidered our original decision and now have no objections to the use of
`the proprietary name, Xalkori, for this product.
`If you have any questions or need further clarification, contact Sarah Simon, OSE Project
`Manager, at 301-796-5205.
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`4.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Xalkori, and have concluded
`that it is acceptable.
`The proposed proprietary name, Xalkori, will be re-reviewed 90 days prior to the
`approval of the NDA. If we find the name unacceptable following the re-review, we will
`notify you.
`If any of the proposed product characteristics are altered prior to approval of the
`marketing application, the proprietary name should be resubmitted for review.
`If you have any questions regarding the contents of this letter or any other aspects of the
`proprietary name review process, call Sarah Simon, Regulatory Project Manager in the Office of
`Surveillance and Epidemiology, at 301-796-5205. For other information regarding this
`application contact Diane Hanner, OND Regulatory Project Manager at 301-796-4058.
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`Reference ID: 2965972
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`4
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`(b) (4)
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`(b) (4)
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`REFERENCES
`1. Baugh, Denise. Proprietary Name Review, Xalkori (Criotinib) Capsule,
`250 mg, OSE Review 2010-1790, dated February 8, 2011.
`2. Preliminary drug usage data retrieved by Lubna Merchant on June 22, 2011, from SDI's
`Vector Alpha database.
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`Reference ID: 2965972
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`5
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`(b) (4)
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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/
`----------------------------------------------------
`
`TODD D BRIDGES on behalf of DENISE V BAUGH
`06/24/2011
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`KELLIE A TAYLOR
`06/27/2011
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`Reference ID: 2965972
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