CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-192
`
`PROPRIETARY NAME REVIEW! S l
`
`

`

`Department of Health and Human Services
`
`Public Health Service
`
` Office of Surveillance and Epidemiology
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Date:
`
`To:
`
`Through:
`
`From:
`
`February 11, 2009
`
`Thomas Laughren, MD, Director
`Division of Psychiatry Products
`
`Todd Bridges, RPh, Team Leader
`Denise Toyer, PharmD, Deputy Director
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Diane C. Smith, PharmD, Safety Evaluator '
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Subject:
`
`Proprietary Name Review
`
`Drug Name(s):
`
`Fanapt (Iloperidone) Tablets
`1mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg
`
`Application Type/Number: NDA # 22-192
`
`Applicant:
`
`Vanda Pharmaceuticals
`
`OSE RCM #:
`
`2009-69
`
`V ***This document contains proprietary and confidential information that should not be released
`to the public.***
`
`

`

`CONTENTS
`
`EXECUTIVE SUMMARY ............................................................................................................. 3
`
`1 BACKGROUND ............................................... 3
`1 . 1
`Introduction .................................................................................................................... 3
`
`1.2
`1.3
`
`Regulatory History ......................................................................................................... 3
`Product Information ....................................................................................................... 3
`
`2 METHODS AND MATERIALS ............................................................................................ 4
`
`3
`
`4
`5
`
`6
`
`Proprietary Name Risk Assessment ............................................................................... 4
`2.1
`RESULTS .............................................................................................................................. 10
`
`Proprietary Name Risk Assessment ............................................................................. 10
`3.1
`DISCUSSION ....................................................................................................................... 11
`CONCLUSIONS ................................................................................................................... 1 1
`
`RECOMMENDATIONS ................................................................................................... 12
`
`6.1
`
`Comments to the Division............................................................................................ 12
`
`Comments to the Applicant......................V.................................................................... 1 2
`6.2
`REFERENCES ...................................................................................................................... 13
`7
`APPENDICES ............................................................................................................................... 15
`
`

`

`EXECUTIVE SUMMARY
`
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Fanapt, is not -
`vulnerable to name confusion that could lead to medication errors. As such, we have no objections to the
`use of the proprietary name, Fanapt, for this product. The Division of Psychiatry Products concurs with
`this assessment.
`
`However, if any of the proposed product characteristics as stated in this review are altered, DMEPA
`rescinds this Risk Assessment finding, and the name must be resubmitted for review. In the event that
`our Risk Assessment finding is rescinded, the evaluation of the name on resubmission is independent of
`the previous Risk Assessment and, as such, the conclusions on re-review of the name are subject to
`change. Additionally, if the product approval is delayed beyond 90 days from the date of this review, the
`proposed name must be resubmitted for evaluation.
`
`1
`
`BACKGROUND
`
`1.1
`
`INTRODUCTION
`
`This review is in response to a request from the Division of Psychiatry Products for assessment of the
`proprietary name, Fanapt, regarding potential name confusion with other proprietary or established drug
`names. Labels and labeling will be evaluated in a separate forthcoming review (OSE review # 2009—70).
`
`Additionally, the Applicant submitted an independent analysis of the name by
`‘- subsidiary of
`M---———_.—- for review and comment.
`
`M4)
`
`1.2
`
`REGULATORY HISTORY
`
`The Division of Medication Error Prevention and Analysis objected to the primary proposed proprietary
`name Fiapta in OSE Review 2007-537, dated April 14, 2008, because of orthographic similarity and
`overlapping product characteristics to Lipitor. Subsequently, DMEPA reviewed the Applicant’s
`secondary name, Fanapta, in OSE Review 2007-538 dated June 3, 2008. DMEPA objected to the name
`Fanapta because the name had orthographic similarities and overlapping product characteristics with
`Lunesta. Thus, in a letter dated June 6, 2008, the Applicant was asked to submit two alternate proprietary
`names for review. As a result, Vanda Pharmaceuticals submitted a request for proposed proprietary name
`review of the proprietary name, Fanapt, on November 19, 2008.
`
`1.3
`
`PRODUCT INFORMATION
`
`Fanapt (Iloperidone) is an atypical antipsychotic agent indicated for the acute treatment of schizophrenia
`in adults. The recommended'dose is 12 mg to 24 mg per day administered twice daily (BID) based on
`clinical response. This target dose range should be achieved through the following daily dosage
`adjustments until the desired maintenance dose is achieved: 1 mg BID, 2 mg BID, 4 mg BID, 6 mg BID,
`8 mg BID, 10 mg BID and 12 mg BID on days 1, 2, 3, 4, 5, 6 and 7, respectively.
`
`

`

`Fanat will be su- died as follows:
`
` Professional
`
`2 METHODS AND MATERIALS
`
`This section consists of the methods and materials used by the DMEPA staff conducting a proprietary
`name risk assessment (see 2.1 Proprietary Name Risk Assessment). The primary focus for all of the
`assessments is to identify and remedy potential sources of medication error prior to drug approval. Our
`Division defines a medication error as any preventable event that may cause or lead to inappropriate
`medication use or patient harm while the medication is in the control of the health care professional,
`patient, or consumer. I
`
`2.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name, Fanapt, and the proprietary and established names of drug products existing in the
`marketplace and those pending IND, BLA, NDA, and ANDA products currently under review by CDER.
`
`For the proprietary name, Fanapt, the DMEPA staff search a standard set of databases and information
`sources to identify names with orthographic and phonetic similarity (see section 2.1.1 for detail) and held
`a CDER Expert Panel discussion to gather professional opinions on the safety of the proposed proprietary
`name (see section 2.1.3). The Division of Medication Error Prevention and Analysis also conducts
`internal FDA prescription analysis studies (see 2.1.2), and, when provided, external prescription analysis
`studies (see 2.1.5) results are considered and incorporated into the overall risk assessment.
`
`The Safety Evaluator assigned to the Proprietary Name Risk Assessment‘is responsible for considering
`the collective findings, and provides an overall risk assessment of the proposed proprietary name (see
`detail 2.4). The overall risk assessment is based on the findings of a Failure Mode and Effects Analysis
`(FMEA) of the proprietary name, and is focused on the avoidance of medication errors. FMEA is a
`systematic tool for evaluating a process and identifying where and how it might fail. 2 FMEA is used to
`
`I National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerp.orglaboutMedEn-ors.html. Last accessed 10/11/2007.
`
`2 Institute for Healthcare Improvement (II-ll). Failure Modes and Effects Analysis. Boston. lHI:2004.
`
`

`

`n.a
`
`analyze Whether the drug names identified with look— and/or sound-alike similarity to the proposed name
`could cause confusion that subsequently leads to'medication errors in the clinical setting. The Division of
`Medication Error Prevention and Analysis defines a medication error as any preventable event that may
`cause or lead to inappropriate medication use or patient harm while the medication is in the control of the
`health care professional, patient, or consumer. ' DMEPA uses the clinical expertise of our staff to
`anticipate the conditions of the clinical setting that the product is likely to be used in based on the
`characteristics of the proposed product.
`
`In addition, the product characteristics provide the context for the verbal and written communication of '
`the drug names and can interact with the orthographic and phonetic attributes of the names to increase the
`risk of confusion when there is overlap, or, in some instances, decrease the risk of confusion by helping to
`differentiate the products through dissimilarity. As such, the staff considers the product characteristics
`associated with the proposed drug throughout the risk assessment, since the product characteristics of the
`proposed may provide a context for communication of the drug name and ultimately determine the use of
`the product in the usual clinical practice setting.
`
`Typical product characteristics considered when identifying drug names that could potentially be
`confused with the proposed drug name include, but are not limited to established name of the proposed
`product, the proposed indication, dosage form, route of administration, strength, unit of measure, dosage
`units, recommended dose, typical quantity or volume, frequency of administration, product packaging,
`storage conditions, patient population, and prescriber population. Because drug name confusion can
`occur at any point in the medication use process, we consider the potential for confusion throughout the
`entire US. medication use process, including drug procurement, prescribing and ordering, dispensing,
`administration, and monitoring the impact of the medication.2
`'
`
`2.1.1 Search Criteria
`
`DMEPA considers the spelling of the name, pronunciation of the name when spoken, and appearance of
`the name when scripted as outlined in Appendix A.
`
`For this review, particular consideration was given to drug names beginning with the letter ‘I’ when
`searching to identify potentially similar drug names, as 75% of the confused drug names reported by the
`USP-ISMPMedication Error Reporting Program involve pairs beginning with the same letter.3’4
`
`To identify drug names that may look similar to Fanapt, the staff also consider the orthographic
`appearance of the name on lined and unlined orders. Specific attributes taken into consideration include
`the length of the name (6 letters), upstrokes (two, capital letter ‘F’ and ‘t’), downstrokes (one, lower case
`‘p’), cross-strokes (two, ‘F’ and‘t’), and dotted letters (none). Additionally, several letters in Fanapt may
`be vulnerable to ambiguity when scripted, including the letter ‘F’ may appear as the letter ‘T’, ‘L’, ‘2’ ‘I’
`or ‘J’; lower case ‘a’ may appear as lower case ‘e’, ‘c’ and ‘0’; lower case ‘n’ may appear as a lower case
`‘m’, ‘r’; ‘h’, ‘u’ ‘s’, or ‘v’; lower case ‘p’ may appear as ‘x’ and ‘y’; lower case ‘t’ may appear as a lower
`case ‘f’, ‘r’, ‘l’ or ‘i’. As such, the DMEPA also considers these alternate appearances when identifying
`drug names that may look similar to Fanapt.
`
`' National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerg.org/aboutMedErrors.html. Last accessed 10/11/2007.
`
`2 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`
`3 Institute for Safe Medication Practices. Confused Drug name List (1996-2006). Available at
`http://www.ismg.orgZTools/confuseddrugnamespdf
`
`4 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artificial Intelligence in
`Medicine (2005)
`
`

`

`When searching to identify potential names that may sound similar to Fanapt, the DMEPA staff searches
`for names with similar number of syllables in the name (2 syllables), stresses (FA—napt or fa—NAPT), and
`placement of vowel and consonant sounds.
`In addition, several letters in Fanapt may be subject to
`interpretation when spoken, including the letter ‘F’ may be interpreted as ‘Ph’, ‘V’, or ‘Fe’; the letter ‘a’
`may be interpreted as the letter ‘e’ or ‘eh’ and the letter ‘t’ may be interpreted as ‘te’, ‘teh’ or ‘tuh’. The
`Applicant’s intended pronunciation of the proprietary name could not be expressly taken into
`consideration, as this was not provided with the proposed name submission.
`
`The DMEPA staff also considers the product characteristics associated with the proposed drug throughout
`the identification of similar drug names, since the product characteristics of the proposed drug ultimately
`determine the use of the productin the clinical practice setting. For this review, the DMEPA staff was
`provided with the following information about the proposed product: the proposed proprietary name
`(Fanapt), the established name (Iloperidone), proposed indication (treatment of schizophrenia), strength
`(1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg), dose (can be respective strength), frequency of
`administration (twice daily), route (oral) and dosage form of the product (tablet). Appendix A provides a
`more detailed listing of the product characteristics DMEPA general take into consideration.
`
`Lastly, DMEPA also considers the potential for the proposed name to inadvertently function as a source
`of error for reasons other than name confusion. Postmarketing experience has demonstrated that
`proprietary names (or components of the proprietary name) can be a Source of error in a variety of ways.
`As such, these breader safety implications of the name are considered and evaluated throughout this
`assessment and DMEPA provides additional comments related to the safety of the proposed name or
`product based on their professional experience with medication errors.
`
`2.1.1.1 Database and Information Sources
`
`The proposed proprietary name, Fanapt, was provided to the DMEPA staff to conduct a search of the
`internet, several standard published drug product reference texts, and FDA databases to identify existing
`and proposed drug names that may sound-alike or look—alike to Fanapt using the criteria outlined in 2.1.1.
`A standard description of the databases used in the searches is provided in Section 6.2. To complement
`the process, the DMEPA staff use a computerized method of identifying phonetic and orthographic
`similarity between medication names. The program, Phonetic and Orthographic Computer Analysis
`(POCA), uses complex algorithms to select a list of names from a database that have some similarity
`(phonetic, orthographic, or both) to the trademark being evaluated. Lastly, DMEPA reviews the USAN
`stem list to determine if any USAN stems are present within the proprietary name. The findings of the
`individual Safety Evaluators were then pooled and presented to the Expert Panel.
`
`2.1.1.2 CDER Expert Panel Discussion
`
`An Expert Panel Discussion is held by DMEPA to gather CDER professional opinions on the safety of
`the product and the proprietary name, Fanapt. Potential concerns regarding drug marketing and
`promotion related to the proposed names are also discussed. This group is composed of DMEPA and
`representatives from the Division of Drug Marketing, Advertising, and Communications (DDMAC).
`
`The pooled results of DMEPA staff were presented to the Expert Panel for consideration. Based on the
`clinical and professional experiences of the Expert Panel members, the Panel may recommend the
`addition of names, additional searches by the Safety Evaluator to supplement the pooled results, or
`general advice to consider when reviewing the proposed proprietary name.
`
`2.1.2
`
`FDA Prescription Analysis Studies
`
`Three separate studies are conducted within the Centers of the FDA for the proposed proprietary name to
`determine the degree of confusion of Fanapt with marketed US. drug names (proprietary and established)
`due to similarity in visual appearance with handwritten prescriptions or verbal pronunciation of the drug
`
`

`

`name. The studies employ a total of 123 healthcare professionals (pharmacists, physicians, and nurses),
`and attempts to simulate therprescription ordering process. The results are used by the Safety Evaluator to
`identify any orthographic or phonetic vulnerability ofthe proposed name to be misinterpreted by
`healthcare practitioners.
`
`In order to evaluate the potential for misinterpretation of Fanapt in handwriting and verbal
`communication of the name, inpatient medication orders and outpatient prescriptions are written, each
`consisting of a combination of marketed and unapproved drug products, including the proposed name.
`These prescriptions are optically scanned and one prescription is delivered to a random sample of 123
`participating health professionals via e-mail. In addition, a verbal prescription is recorded on voice mail.
`The voice mail messages are then sent to a random sample of the participating health professionals for
`their interpretations and review. After receiving either the written or verbal prescription orders, the
`participants send their interpretations of the orders via e-mail to the medication error staff.
`
`Figure l. Fanapt Study (conducted on Januagy 23, 20091
`
`Outpatient Prescription:
`‘
`
`1 tablet by mouth bid
`
`Fanapt 12 mg
`# 60
`
`2.1.3 External Proprietary Name Risk Assessment
`
`For this product, the Applicant submitted an external evaluation of the proposed proprietary name,
`Fanapt. The Division of Medication Error Prevention and Analysis conducts an independent analysis and
`evaluation of the data provided, and responds to the overall findings of the assessment. When the
`external proprietary name risk assessment identifies potentially confusing names that were not captured in
`DMEPA’s database searches or in the Expert Panel Discussion, these names are included in the Safety
`Evaluator’s Risk Assessment and analyzed independently by the Safety Evaluator to determine if the
`potentially confusing name could lead to medication errors in usual practice settings.
`
`After the Safety Evaluator has determined the overall risk assessment of the proposed name, the Safety
`Evaluator compares the findings of their overall risk assessment with the findings of the proprietary name
`risk assessment submitted by the Applicant. The Safety Evaluator then determines whether the Division’s
`risk assessment concurs or differs with the findings. When the proprietary name risk assessments differ,
`the Division of Medication Error Prevention and Analysis provides a detailed explanation of these
`differences.
`
`

`

`2.1.4 Commentsfrom the Division ofPsych iatty Products (DPP)
`
`DMEPA requests the regulatory division in the Office of New Drugs responsible for the application for
`their comments and/or clinical/other concerns on the proposed proprietary name at the initial phase of the
`name review. Additionally, when applicable, at the same time DMEPA requests concurrence/non-
`concurrence with DDMAC’s decision on the name. Any comments or concerns are addressed in the
`safety evaluator’s assessment.
`
`The Review Division is contacted a second time following our analysis of the proposed name. At this
`point, DMEPA conveys their decision to accept or reject the name. The regulatory division is requested
`to concur /not concur with DMEPA’s final decision.
`
`2.]. 5
`
`Safety Evaluator Risk Assessment ofthe Proposed Proprietary Name
`
`Based on the criteria set forth in Section 2.1.1, the Safety Evaluator Risk Assessment applies their
`individual expertise gained from evaluating medication errors reported to FDA to conduct a Failure Mode
`and Effects Analysis and provide an overall risk of name confusion. Failure Mode and Effects Analysis
`(FMEA) is a systematic tool for evaluating a process and identifying where and how it might fail.1 When
`applying FMEA to assess the risk of a proposed proprietary name, the Division of Medication Error
`Prevention and Analysis seeks to evaluate the potential for a proposed name to be confused with another
`drug name as a result of the name confusion and cause errors to occur in the medication use system.
`FMEA capitalizes on the predictable and preventable nature of medication errors associated with drug
`name confusion. FMEA allows the Agency to identify the potential for medication errors due to look- or
`sound-alike drug names prior to approval, where actions to overcome these issues are easier and more
`effective then remedies available in the post-approval phase.
`
`In order to perform an FMEA of the proposed name, the Safety Evaluator must analyze the use of the
`product at all points in the medication use system. Because the proposed product is not yet marketed, the
`Safety Evaluator anticipates the use of the product in the usual practice settings by considering the clinical
`and product characteristics listed in Appendix A. The Safety Evaluator then analyzes the proposed
`proprietary name in the context of the usual practice setting and works to identify potential failure modes
`and the effects associated with the failure modes.
`
`In the initial stage of the Risk Assessment, the Safety Evaluator compares the proposed proprietary name
`to all of the names gathered from the above searches, expert panel evaluation, and studies, and identifies
`potential failure modes by asking: “Is the name Fanapt convincingly similar to another drug name, which
`may cause practitioners to become confused at any point in the usual practice setting?” An affinnative
`answer indicates a failure mode and represents a potential for Fanapt to be confused with another
`proprietary or established drug name because of look- or sound-alike similarity. If the answer to the
`question is no, the Safety Evaluator is not convinced that the names posses similarity that would cause
`confusion at any point in the medication use system and the name is eliminated from further review.
`
`In the second stage of the Risk Assessment, all potential failure modes are evaluated to determine the
`likely effect of the drug name confusion, by asking “Could the confusion of the drug names conceivably
`result in medication errors in the usual practice setting?” The answer to this question is a central
`component of the Safety Evaluator’s overall risk assessment of the proprietary name. If the Safety
`Evaluator determines through FMEA that the name similarity would ultimately not be a source of
`medication errors in the usual practice setting, the name is eliminated from further analysis. However, if
`the Safety Evaluator determines through FMEA that the name similarity could ultimately cause
`medication errors in the usual practice setting, the Safety Evaluator will then recommend that an alternate
`proprietary name be used. In rare instances, the FMEA findings may provide other risk-reduction
`
`‘ Institute for Healthcare Improvement (ll-II). Failure Modes and Effects Analysis. Boston. IHI:2004.
`
`

`

`strategies, such as product reformulation to avoid an overlap in strength or an alternate modifier
`designation may be recommended as a means of reducing the risk of medication errors resulting from
`drug name confusion.
`
`DMEPA will object to the use of proposed proprietary name when the one or more of the following
`conditions are identified in the Safety Evaluator’s Risk Assessment:
`
`1. DDMAC finds the proposed proprietary name misleading from a promotional perspective, and
`the review Division concurs with DDMAC’s findings. The Federal Food, Drug, and Cosmetic
`Act provides that labeling or advertising can misbrand a product if misleading representations are
`made or suggested by statement, word, design, device, or any combination thereof, whether
`through a trade name or otherwise.
`[21 U.S.C 321(n); see also 21 U.S.C. 352(a) & (n)].
`
`2. DMEPA identifies that the proposed proprietary name is misleading because of similarity in .
`spelling or pronunciation to another proprietary or established name of a different drug or
`ingredient [CFR 201 . l 0.(C)(5)].
`
`3. FMEA identifies potential for confusion between the proposed proprietary name and other
`proprietary or established drug names, ES! demonstrates that medication errors are likely to result
`from the drug name confusion under the conditions of usual clinical praCtice.
`
`'
`
`4. The proposed proprietary name contains an USAN stem, particularly in a manner that is
`contradictory to the USAN Council’s definition.
`
`5. DMEPA staff identify a potential source of medication error within the proposed proprietary
`name. The proprietary name may be misleading, or inadvertently introduce ambiguity and
`confusion that leads to errors. Such errors may not necessarily involve confusion between the
`proposed drug and another drug product.
`
`In the event that DMEPA objects to the use of the proposed proprietary name, based upon the potential
`for confusion with another proposed (but not yet approved) proprietary name, we will provide a
`contingency objection based on the date of approval: whichever product is awarded approval first has the
`right to the use the name, while DMEPA will recommend that the second product to reach approval seek
`an alternative name.
`
`If none of these conditions are met, then DMEPA will not object to the use of the proprietary name. If
`any of these conditions are met, then we will object to the use of the proprietary name. The threshold set
`for objection to the proposed proprietary name may seem low to the Applicant; however, the safety
`concerns set forth in criteria-1 through 5 are supported either by FDA Regulation or by external
`healthcare authorities, including the Institute of Medicine, World Health Organization, Joint Commission,
`and Institute for Safe Medication Practices, which have examined medication errors resulting from look-
`or sound-alike drug names and called for Regulatory Authorities to address the issue prior to approval.
`
`Furthermore, DMEPA contends thatthe threshold set for the Proprietary Name Risk Assessment is
`reasonable because proprietary drug name confusion is a predictable and preventable source of
`medication error that, in many instances, can be identified and remedied prior to approval to avoid patient
`harm.
`
`Additionally, postmarketing experience has demonstrated that medication errors resulting from drug name
`confusion are notoriously difficult to remedy post-approval. Educational efforts and so on are low-
`leverage strategies that have proven to have limited effectiveness at alleviating the medication errors
`involving drug name confusion. Higher-leverage strategies, such as drug name changes, have been
`undertaken in the past; but at great financial cost to the Applicant, and at the expense of the public
`welfare, not to mention the Agency’s credibility as the authority responsible for the approving the error-
`prone proprietary name. Moreover, even after Applicant’s have changed a product’s proprietary name in
`the post-approval phase, it is difficult to eradicate the original proprietary name from practitioner’s
`
`

`

`vocabulary, and as such, the Agency has continued to receive reports of drug name confusion long after a
`name change in some instances. Therefore, DMEPA believes that post-approval efforts at reducing name
`confusion errors should be reserved for those cases in which the potential for name confusion could not
`be predicted prior to approval (see limitations of the process).
`
`If DMEPA objects to a proposed proprietary name on the basis that drug name confusion could lead to
`medication errors, the FMEA process is used to identify strategies to reduce the risk of medication errors.
`We are likely to recommend that the Applicant select an alternative proprietary name and submit the
`alternate name to the Agency for DMEPA to review. However, in rare instances FMEA may identify
`plausible strategies that could reduce the risk of medication error of the currently proposed name, and so
`DMEPA may be able to provide the Applicant with recommendations that reduce or eliminate the
`potential for error would render the proposed name acceptable.
`
`3 RESULTS
`
`3.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`3.1.] Database and Information Sources
`
`In total, twenty—nine names were identified as having some similarity to the name Fanapt. Twenty-two of
`the twenty-nine names thought to look like Fanapt include: Lunesta, Panacet, Femhrt, Timoptic
`Trusopt, Fanaxal, Bancap, Tanafed. Tannate, Fiapta***, Tanayw :, Tamiflu, Panafil, Fanasal,
`Famopril, Farabant, Tovaltw—v , Fablyn, Faropem and Danazol. Three names (Phanate,
`
`Penlac and Tanac) were thought to sound like Fanapt. Finally, feur names (Fanapta***, Fempatch,
`Finafta and Fanapt :
`'
`l were thought to look and sound like Fanapt.
`
`On January 9, 2009, the name Fanapt was searched against the United States Adopted Names (USAN)
`stem list and the proposed name was found to contain no USAN stems.
`
`3.1.2 CDER Expert Panel Discussion
`
`The Expert Panel reviewed the pool of names identified by DMEPA staff (see section 3.1.1 above) and
`did not have any additional comments regarding the name Fanapt.
`
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did not offer
`any additional comments related to the proposed name.
`
`3.1.3 FDA Prescription Analysis Studies
`
`A total of 28 practitioners responded to the prescription analysis study, but none of the responses
`overlapped with any existing or proposed drug names. Approximately 28 %of the participants (n=8)
`interpreted the name correctly as “Fanapt,” with the correct interpretation occurring most frequently in the
`Outpatient Prescription study. The remainder of the respondents misinterpreted the name. In the
`Inpatient Medication Order study most respondents misinterpreted the beginning of the name,
`misinterpreting the letters ‘Fa’ as the letters ‘La’ and the second 'a' as the letter ‘0’.
`In the Outpatient
`Prescription study the letters ‘Fa’ in Fanapt was misinterpreted as the letters ‘Ta’, 'Za‘ or 'La'; and the
`second letter ‘a’ was misinterpreted as the letter ‘0’.
`In the Verbal Prescription Study the letters ‘Fa’ was
`misinterpreted as the letters ‘Be’, 'Bi', 'Ve', 'Me', 'Mo' and 'Fi'; the letter ‘t’ was misinterpreted as the letter
`‘5’. See Appendix B for the complete listing of interpretations from the verbal and written prescription
`studies.
`
`10
`
`

`

`'1(4)
`
`all“
`
`3.1.4 Commentsfrom the Division ofPsychiatry Products (DPP)
`
`In response to the OSE January 15, 2009 e-mail, DPP did not forward any comments and/or clinical/other
`concerns on the proposed name at the initial phase of the name review.
`
`DMEPA notified DPP via e-mail that we had found no objections to the proposed proprietary name,
`Fanapt, on February 10, 2009. Per e—mail correspondence from the Division of Psychiatry Products on
`February 11, 2009, they indicated they concur with our assessment of the proposed name, Fanapt.
`
`3.1.5 External Proprietary Name Risk Assessment
`
`In the proposed name risk assessment submitted by the Applicant, .m— 5dentified and evaluated a total
`of five drug names (Parnate, Trusopt, Lunesta, Azopt and Cosopt) thought to have some potential for
`confusion with the name Fanapt \__— evaluated all the names identified for both look and
`sound-alike similarities. Two of the five names (Lunesta and Trusopt) were previously identified in our
`staff searches or Expert Panel Discussion. Three of the five names (Pamate, Azopt and Cosopt) were not
`previously identified in our staff searches, the Expert Panel Discussion, or FDA prescription studies.
`
`3.1. 6 Safety Evaluator Risk Assessment
`
`Independent searches by the primary Safety Evaluator did not identified any additional names thought to
`look or sound similar to Fanapt and represent a potential source of drug name confusion. However, the
`Safety Evaluator re-reviewed the 16 names (Femara, ““TFynefla, Synaptra, Fansidar, Timoptic,
`Fentora, Tinactin, Taractan, Zarnestra, FemPatch, Tanafed, Lipitor, Fareston, Sonata, and Lunesta)
`identified in the previous review for Fanapta (OSE- review # 2007-53 8). Three of these names were
`identified in either the External Proprietary Name Risk Assessment or the Database searches.
`
`As such, a total of forty-five names were analyzed to determine if the drug names could be confused with
`Fanapt and if the drug name confusion would likely result in a medication error.
`
`Thirty-one (31) names lacked orthographic and/or phonetic similarity and were not evaluated further (see
`Appendix C). Two names (Fiapta and Fanapta) were not further reviewed, as these names were th