CENTER FOR DRUG EVALUATION AND
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`RESEARCH
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`
`
`
`
`APPLICATION NUMBER:
`22-264
`22-264
`
`
`APPLICA TION NUMBER:
`
`PROPRIETARY NAME REVIEW(S)
`PROPRIETARY NAME REVIEW! S}
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`

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`
`Date:
`
`To:
`
`Through:
`
`From:
`
`Subject:
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`May 1, 2009
`
`Thomas Laughren, M.D., Director
`Division of Psychiatry Products
`
`Laura Pincock, PharmD, Acting 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)
`Proprietary Name Review
`
`Drug Name(s):
`
`Invega Sustenna (Paliperidone Palmitate) Injection
`25 mg, 50 mg, 75 mg, 100 mg and 150 mg
`Application Type/Number: NDA 22-264
`
`Applicant:
`
`OSE RCM #:
`
`Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
`
`2009-285
`
`
`***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
`Product Information....................................................................................................... 3
`2 METHODS and MATERIALS ............................................................................................... 4
`2.1
`Proprietary Name Risk Assessment............................................................................... 4
`3 RESULTS................................................................................................................................ 9
`3.1
`Proprietary Name Risk Assessment............................................................................... 9
`4 DISCUSSION ......................................................................................................................... 9
`4.1
`Proprietary Name Risk Assessment............................................................................... 9
`5 CONCLUSIONS and RECOMMENDATIONS................................................................... 10
`5.1
`Comments To The Division......................................................................................... 10
`5.2
`Comments To The Applicant....................................................................................... 10
`6 REFERENCES...................................................................................................................... 11
`APPENDICES............................................................................................................................... 13
`
`
`
`2
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`EXECUTIVE SUMMARY
`This re-assessment of the proprietary name Invega Sustenna. The Division of Medication Error
`Prevention and Analysis (DMEPA) found the proposed proprietary name Invega Sustenna, acceptable in
`OSE Review # 2008-117 dated August 5, 2008. Since the last review the Applicant has changed the
`stating dose from
` to 150 mg on treatment day 1, and 100 mg one week later.
`Due to the change in starting dose DMEPA re-reviewed the previous names identified in OSE Review#
`2008-117 dated August 5, 2008, and ten new names which were identified during this review, for their
`similarity to Invega Sustenna. The results of the Failure Mode Effects Analysis found that the proposed
`name, Invega Sustenna, is not vulnerable to name confusion that could lead to medication errors with any
`of the ten names. Thus, the Division of Medication Error Prevention and Analysis does not object to the
`use of the proprietary name, Invega Sustenna, for this product.
`DMEPA considers this a final review, if approval of the NDA is delayed beyond 90 days from the date of
`this review, the Division of Psychiatry should notify DMEPA because the proprietary name must be re-
`reviewed prior to the new approval date.
`
`1 BACKGROUND
`
`1.1
`INTRODUCTION
`The proposed proprietary name, Invega Sustenna, was previously reviewed by DMEPA in 2008 when the
`NDA was first submitted under OSE Consult # 2008-117 without objection. As such, DMEPA will not
`reevaluate the modifier independent of the entire proposed proprietary name in this evaluation of the
`proposed name. Container labels and carton labeling were also provided to be evaluated from a
`medications errors perspective. Review comments on the labels and labeling will be provided under
`separate cover in a forthcoming review (OSE Review # 2009-286).
`
`1.2 PRODUCT INFORMATION
`Invega Sustenna is the proposed name for paliperidone palmitate long-acting injection. Invega Sustenna is
`hydrolyzed to paliperidone, the active metabolite of risperidone. The mechanism of action of
`paliperidone is unknown, but it has been proposed that the therapeutic activity in schizophrenia is
`mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor
`antagonism.
`For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended
`that the tolerability of paliperidone be established prior to initiating treatment with Invega Sustenna. The
`recommended initial dose of Invega Sustenna is 150 mg via intramuscular injection on treatment day 1
`and 100 mg one week later, both administered in the deltoid muscle. The recommended subsequent
`monthly dose is 75 mg; which can be increased or decreased in a range of 25 mg to 150 mg based upon
`individual patient tolerability and/or efficacy. Following the second dose, monthly doses can be
`administered in either the deltoid or gluteal muscle. Invega Sustenna should be administered by a
`healthcare professional, slowly and deeply into the muscle.
`The recommended needle size for administration into the gluteal muscle is the 1 1/2-inch, 22 gauge
`needle. Administration should be made into the upper-outer quadrant of the gluteal area, with injections
`sites alternated between the two gluteal muscles. The recommended needle size for injections in the
`deltoid muscle is determined by the patient's weight. For patients whose weight is greater than or equal to
`90 kg, the 1 1/2 inch, 22 gauge needle is recommended. For those weighing less than 90 kg, the
`1-inch, 23 gauge needle is recommended. Deltoid injections should be alternated between the two deltoid
`muscles.
`
`3
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`(b) (4)
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`Invega Sustenna will be supplied as a kit containing a pre-filled syringe and 2 safety needles (a 1 1/2-inch
`22 gauge safety needle and a 1-inch 23 gauge safety needle) for injection. The pre-filled syringes contain
`25 mg, 50 mg, 75 mg, 100 mg and 150 mg of paliperidone.
`
`2 METHODS AND MATERIALS
`This section describes the methods and materials used by the Division of Medication Error Prevention
`and Analysis (DMEPA) when conducting a proprietary name risk assessment (see 2.1 Proprietary Name
`Risk Assessment). The objective for the assessment is to identify and remedy potential sources of
`medication error prior to drug approval. DMEPA 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. 1
`
`2.1 PROPRIETARY NAME RISK ASSESSMENT
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name, Invega Sustenna, and the proprietary and established names of drug products existing in
`the marketplace and those pending IND, NDA, BLA, and ANDA products currently under review by the
`Agency.
`For the proprietary name, Invega Sustenna, DMEPA staff search a standard set of databases and
`information sources to identify names with orthographic and phonetic similarity (see Sections 2.1.1 for
`detail) and held a Center for Drug Evaluation and Research (CDER) Expert Panel Discussion to gather
`professional opinions on the safety of the proposed proprietary name (see 2.1.1.2). DMEPA normally
`conducts internal CDER prescription analysis studies. When provided, external prescription analysis
`studies 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 2.1.2). 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 analyze whether the drug names identified with look- or sound-alike similarity to the proposed
`name could cause confusion that subsequently leads to medication errors in the clinical setting. DMEPA
`uses the clinical expertise of the 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. Accordingly, the DMEPA staff considers the product
`characteristics associated with the proposed drug throughout the risk assessment because 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
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`2 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
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`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, DMEPA staff considers the potential for confusion
`throughout the entire U.S. medication use process, including drug procurement, prescribing and ordering,
`dispensing, administration, and monitoring the impact of the medication.3
`
`2.1.1 Search Criteria
`DMEPA staff 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 and S’ when
`searching to identify potentially similar drug names, as 75% of the confused drug names reported by the
`USP-ISMP Medication Error Reporting Program involve pairs beginning with the same letter.4,5
`Additionally, since omission of a modifier is cited in the literature as a common cause of medication
`errors6, the DMEPA staff consider ‘Invega Sustenna’ as a complete name as well as ‘Invega,’ the root
`name alone.
`To identify drug names that may look similar to Invega Sustenna, 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 (six letters for Invega and eight letters for Sustenna), upstrokes (three; capital
`letters ‘I ’and ‘S’, lower case letters ‘t’, downstrokes (one, lower case ‘g’), cross-strokes (one lower case
`‘t’’), and dotted letters (none). Additionally, several letters in Invega may be vulnerable to ambiguity
`when scripted, including the letter ‘I’ may appear as ‘J’, ‘L’; lower case ‘n’ may appear as a lower case
`‘m’, ‘u’, ‘x’, ‘r’, ‘h’, or ‘s’; lower case ‘v’ may appear as lower case ‘r’ or ‘n’; lower case ‘e’ may appear
`as a lower case ‘l’or ‘o’; lower case ‘g’ may appear as lower case ‘p’ or ‘q’; and lower case ‘a’ may
`appear as lower case ‘o’. Additionally, several letters in Sustenna may be vulnerable to ambiguity when
`scripted, including the letter ‘S’ may appear as upper case ‘G’; lower case ‘u’ may appear as lower case
`‘n’ or ‘v’; lower case ‘s’ may appear as lower case ‘r’ or ‘n’; lower case ‘t’ may appear as lower case ‘l’
`or ‘x’; lower case ‘e’ can appear as lower case ‘l’ or ‘i’; lower case ‘n’ or ‘nn’ may appear as a lower case
`‘m’, ‘n’, ‘v’ or ‘w’; and lower case ‘a’ may appear as ‘o’. As such, the staff also considers these alternate
`appearances when identifying drug names that may look similar to Invega Sustenna.
`When searching to identify potential names that may sound similar to Invega Sustenna, the DMEPA staff
`search for names with similar number of syllables (three and three), stresses (IN-veg-ah or in-VEG-AH
`and SUST-en-nah or Sus-ten-AH), and placement of vowel and consonant sounds. Additionally, the staff
`also considers that pronunciation of parts of the name can vary such as ‘In-’ may sound like ‘En’. 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. Moreover, names are often
`mispronounced and/or spoken with regional accents and dialects, so other potential pronunciations of the
`name are considered.
`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
`
`
`3 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`4 Institute for Safe Medication Practices. Confused Drug name List (1996-2006). Available at
`http://www.ismp.org/Tools/confuseddrugnames.pdf
`5 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artificial Intelligence in
`Medicine (2005)
`6 Lesar TS. Prescribing Errors Involving Medication Dosage Forms. J Gen Intern Med. 2002; 17(8): 579-587.
`
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`determine the use of the product in the clinical practice setting. For this review, DMEPA staff were
`provided with the following information about the proposed product: proposed proprietary name (Invega
`Sustenna), established name (paliperidone palmitate), proposed indication of use (schizophrenia), strength
`(25 mg, 50 mg, 75 mg, 100 mg and 150 mg), dose (150 mg on treatment day 1, then 100 mg one week
`later, subsequent doses of 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg are once a month), frequency of
`administration (monthly), route (intramuscularly) and dosage form of the product (prefilled syringe for
`injection). Appendix A provides a more detailed listing of the product characteristics that DMEPA staff
`generally take into consideration.
`Lastly, DMEPA staff considers the potential for the proposed name to inadvertently function as a source
`of error for reasons other than name confusion. Post-marketing experience has demonstrated that
`proprietary names (or components of the proprietary name) can be a source of error in a variety of ways.
`Consequently, these broader safety implications of the name are considered and evaluated throughout this
`assessment and DMEPA staff 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, Invega Sustenna, 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 Invega Sustenna using the criteria
`outlined in 2.1.1. A standard description of the databases used in the searches is provided in Section 7.
`To complement the process, DMEPA staff used 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, the DMEPA staff
`review the USAN stem list to determine if any USAN stems are present within the proprietary name. The
`individual findings of the multiple safety evaluators were then pooled and presented to the CDER Expert
`Panel.
`
`2.1.1.2 FDA 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. The Expert Panel is composed of the Division of Medication
`Errors Prevention and Analysis (DMEPA) staff and representatives from the Division of Drug Marketing,
`Advertising, and Communications (DDMAC). Potential concerns regarding drug marketing and
`promotion related to the proposed name are also discussed.
`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 Safety Evaluator Risk Assessment of the Proposed Proprietary Name
`Based on the criteria set forth in Section 2.1, the Safety Evaluator Risk Assessment applies his/her
`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.7 When
`applying FMEA to assess the risk of a proposed proprietary name, DMEPA seeks to evaluate the potential
`
`
`7 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
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`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 Invega Sustenna convincingly similar to another drug name, which may cause
`
`
` practitioners to become confused at any point in the usual practice setting?”
`An affirmative answer indicates a failure mode and represents a potential for the name, Invega Sustenna,
`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 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 201.10.(C)(5)].
`
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`3. FMEA identifies potential for confusion between the proposed proprietary name and other
`proprietary or established drug names, and 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 identifies 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, DMEPA 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 DMEPA 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 IOM, WHO, Joint Commission, and ISMP, who 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 that the 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, post-marketing 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 Section 4 for 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.
`DMEPA is 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.
`
`8
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`

` RESULTS
`
` 3
`
`3.1 PROPRIETARY NAME RISK ASSESSMENT
`
`3.1.1 Database and Information Sources
`The search yielded a total of nineteen names as having some similarity to the name 'Invega Sustenna' or
`either of the name components 'Invega' or 'Sustenna'.
`Ten of the nineteen names were thought to look like Invega or Sustenna. These include Invanz,
`Invagesic, Lovaza, Inspra,
`, Indinavir Sulfate, Invirase, Sustagen, Sustaire, Sufenta. Five of
`the nineteen names (Senna, Henna, Systane, Systen and Systane Free) were thought to sound like
`Sustenna. The remaining four names, Invega, Sustiva, Susano and
`, were thought to look and
`sound similar to Invega Sustenna.
`Additionally, DMEPA staff did not identify any United States Adopted Names (USAN) stems in the
`name, Invega Sustenna, as of March 11, 2009.
`
`3.1.2 Expert Panel Discussion
`The Expert Panel reviewed the pool of names identified by DMEPA staff (see section 3.1.1. above) and
`did not note any additional names thought to have orthographic or phonetic similarity to Invega Sustenna.
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did not offer
`any additional comments relating to the proposed name.
`
`3.1.3 Safety Evaluator Risk Assessment
`Nine of the names identified for this review were evaluated in DMEPA's previous review for the name
`Invega Sustenna (OSE Review 2008-117). Although the initial recommended dose has changed (from
` to 150 mg), this change does not impact the analysis of the names previously reviewed. The
`remaining ten newly identified names were analyzed to determine if the drug names could be confused
`with Invega Sustenna and if the drug name confusion would likely result in a medication error.
`Failure mode and effect analysis was then applied to determine if the potential name could potentially be
`confused with any of the ten names and lead to medication errors. This analysis determined that the name
`similarity between Invega Sustenna and the identified names was unlikely to result in medication errors
`with any of the ten products identified for the reasons presented in Appendices C-F.
`
`4 DISCUSSION
`
`4.1 PROPRIETARY NAME RISK ASSESSMENT
`Nineteen names were evaluated for their potential similarity to the proposed name, Invega Sustenna. The
`findings of our FMEA indicates that the proposed name is not vulnerable to name confusion that could
`lead to medication errors for the reasons outlined in Appendices C through F.
`
`9
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`(b) (4)
`
`(b) (4)
`
`(b) (4)
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` 5
`
` CONCLUSIONS AND RECOMMENDATIONS
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Invega Sustenna, is not
`vulnerable to name confusion that could lead to medication errors. Thus the Division of Medication Error
`Prevention and Analysis has no objection to the use of the proprietary name, Invega Sustenna, for this
`product. However, if any of the proposed product characteristics as stated in this review are altered prior
`to approval of the product, the Division of Medication Error Prevention and Analysis rescinds this Risk
`Assessment finding, and recommends that the name 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 day from the date of this review, the proposed
`name must be resubmitted for evaluation.
`5.1 COMMENTS TO THE DIVISION
`We would appreciate feedback on the final outcome of this review. We would be willing to meet with the
`Division for further discussion, if needed. Please copy DMEPA on any communication to the Applicant
`with regard to this review. If you have further questions or need clarifications, please contact
`Abolade Adeolu, project manager, at 301-796-4264.
`
`5.2 COMMENTS TO THE APPLICANT
`
`5.2.1 Proprietary Name
`We have completed our review of the proposed proprietary name, Invega Sustenna, and have concluded
`that it is acceptable.
`The proposed proprietary name, Invega Sustenna, 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 as stated in your submission are altered prior to approval of
`the marketing application, the proprietary name should be resubmitted for review.
`
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` REFERENCES
`
` 6
`
`Micromedex Integrated Index (http://csi.micromedex.com)
`1.
`Micromedex contains a variety of databases covering pharmacology, therapeutics, toxicology and
`diagnostics.
`
`Phonetic and Orthographic Computer Analysis (POCA)
`2.
`POCA is a database which was created for the Division of Medication Error Prevention and Analysis,
`FDA. As part of the name similarity assessment, proposed names are evaluated via a
`phonetic/orthographic algorithm. The proposed proprietary name is converted into its phonemic
`representation before it runs through the phonetic algorithm. Likewise, an orthographic algorithm exists
`which operates in a similar fashion. This is a database which was created for the Division of Medication
`Error Prevention and Analysis, FDA.
`
`Drug Facts and Comparisons, online version, St. Louis, MO (http://factsandcomparisons.com)
`3.
`Drug Facts and Comparisons is a compendium organized b