CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`205103Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`PROPRIETARY NAME REVIEW
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the public***
`
`Date of This Review:
`May 26, 2016
`Application Type and Number: NDA 205103
`Product Name and Strength:
`Yosprala (Aspirin and Omeprazole)
`Delayed-release Tablets
`325 mg/40 mg and 81 mg/40 mg
`Multi Ingredient
`Rx
`Pozen Inc.
`March 14, 2016
`2016- 3056377
`Sherly Abraham, R.Ph
`Mishale Mistry, Pharm.D.
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Reference ID: 3937130
`
`1
`
`

`

`1
`
`Contents
`INTRODUCTION ...........................................................................................................1
`1.1
`Regulatory History................................................................................................1
`1.2
`Product Information.............................................................................................1
`RESULTS.......................................................................................................................1
`2.1 Misbranding Assessment .....................................................................................1
`2.2
`Safety Assessment................................................................................................2
`CONCLUSIONS .............................................................................................................3
`3.1
`Comments to the Applicant .................................................................................4
`REFERENCES ................................................................................................................5
`4
`APPENDICES........................................................................................................................6
`
`2
`
`3
`
`
`
`Reference ID: 3937130
`
`2
`
`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Yosprala, from a safety and misbranding
`perspective. The sources and methods used to evaluate the proposed name are outlined in the
`reference section and Appendix A respectively. The Applicant did not submit an external name
`study for this proposed proprietary name.
`
`REGULATORY HISTORY
`1.1
`Pozen submitted the proposed proprietary name, Yosprala, on July 17, 2013, under NDA
`205103. On September 12, 2013, Division of Medication Error Prevention and Analysis
`(DMEPA) conditionally approved the proposed name1. However, the Division of
`Gastroenterology and Inborn Error Products (DGIEP) issued a Complete Response (CR) for the
`application on April 25, 2014. Pozen re-submitted the NDA to the Division on June 30, 2014,
`and resubmitted the name, Yosprala, for evaluation on July 21, 2014 per our request. On
`September 29, 2014, DMEPA conditionally approved the proposed name2. On December 16,
`2014, another CR letter was issued due to continued manufacturing facility deficiencies. When
`application was resubmitted on March 14, 2016, the proposed name was also resubmitted for
`review.
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the March 14, 2016, proprietary name
`submission.
`
`Intended Pronunciation: yo SPRA lah
` Active Ingredient: Aspirin and Omeprazole
`
`Indication of Use: indicated for patients who require aspirin for secondary prevention of
`cardiovascular and cerebrovascular events and who are at risk of developing aspirin
`associated gastric ulcers.
`The aspirin component of YOSPRALA is indicated for:
`o 1) reducing the combined risk of death and nonfatal stroke in patients who have had
`ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli,
`2)reducing the combined risk of death and nonfatal MI in patients with a previous
`MI or unstable angina pectoris, 3)reducing the combined risk of MI and sudden
`
`1 Khosla,L..Proprietary Name Review for Yosprala (NDA 205103). Silver Spring (MD): Food and Drug Administration,
`Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of Medication Error
`Prevention and Analysis (US); 2013 Sept 12. 10 p. OSE RCM No.: 2013-.1683
`
`2 Abraham S. Proprietary Name Review for Yosprala (NDA 205103). Silver Spring (MD): Food and Drug
`Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of
`Medication Error Prevention and Analysis (US); 2014 Sept 29. 10 p. OSE RCM No.: 2014-25901.
`
`Reference ID: 3937130
`
`3
`
`

`

`death in patients with chronic stable angina pectoris, 4)use in patients who have
`undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or
`Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-
`existing condition for which aspirin is already indicated.
`The omeprazole component of YOSPRALA is indicated for decreasing the risk of
`developing aspirin associated gastric ulcers in patients at risk for developing aspirin-
`associated gastric ulcers due to age (≥ 55) or documented history of gastric ulcers.
` Route of Administration: Oral
` Dosage Form: Delayed-release Tablets
`
`Strengths: 81 mg delayed release aspirin/40 mg immediate release omeprazole and 325 mg
`delayed release aspirin/40 mg immediate release omeprazole
` Dose and Frequency: One tablet once daily
` How Supplied: Bottles of 30, 90
` tablets
`
`Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled
`Room Temperature].
` Container and Closure Systems: Round shaped bottles, 40 and 60 mL, made of white high
`density polyethylene (HDPE) with a
` screw closure
`
`
`
`
`RESULTS
`2
`The following sections provide information obtained and considered in the overall evaluation of
`the proposed proprietary name.
`
`2.1 MISBRANDING ASSESSMENT
`The Office of Prescription Drug Promotion (OPDP) determined that the proposed name does
`not misbrand the proposed product. DMEPA and the Division of Gastroenterology and Inborn
`Error Products (DGIEP) concurred with the findings of OPDP’s assessment of the proposed
`name.
`
`2.2 SAFETY ASSESSMENT
`The following aspects were considered in the safety evaluation of the name.
`
`2.2.1 United States Adopted Names (USAN) Search
`There is no USAN stem present in the proprietary name3.
`
`3USAN stem search conducted on April 20, 2016.
`
`Reference ID: 3937130
`
`4
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`2.2.2 Components of the Proposed Proprietary Name
`The Applicant did not provide a derivation or intended meaning for the proposed name,
`Yosprala, in their submission. This proprietary name is comprised of a single word that does not
`contain any components (i.e. a modifier, route of administration, dosage form, etc.) that are
`misleading or can contribute to medication error.
`
`2.2.3. FDA Name Simulation Studies
`74 practitioners participated in DMEPA’s prescription studies. The responses did not overlap
`with any currently marketed products nor did the responses sound or look similar to any
`currently marketed products or any products in the pipeline. Appendix B contains the results
`from the verbal and written prescription studies.
`
`2.2.4 Comments from Other Review Disciplines at Initial Review
`In response to the OSE, March 22, 2016 e-mail, the Division of Division of Gastroenterology and
`Inborn Error Products (DGIEP) did not forward any comments or concerns relating to the
`proposed proprietary name at the initial phase of the review.
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Table 1 lists the number of names with the combined orthographic and phonetic score of ≥50%
`retrieved from our POCA search4 organized as highly similar, moderately similar or low
`similarity for further evaluation. We identified 102 names in our POCA search. We had
`identified and evaluated 96 names in our previous proprietary name review.5 We re-evaluated
`the previously identified names of concern considering any lessons learned from recent post-
`marketing experience, which may have altered our previous conclusion regarding the
`acceptability of the name. Our analysis in Table 1 consists of names not previously analyzed.
`
`Table 1. POCA Search Results
`
`Highly similar name pair:
`combined match percentage score ≥70%
`Moderately similar name pair:
`combined match percentage score ≥50% to ≤ 69%
`Low similarity name pair:
`combined match percentage score ≤49%
`
`Number of
`Names
`1
`
`5
`
`0
`
`4 POCA search conducted on April 19, 2016.
`
`5 Abraham S. Proprietary Name Review for Yosprala (NDA 205103). Silver Spring (MD): Food and Drug
`Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of
`Medication Error Prevention and Analysis (US); 2014 Sept 29. 10 p. OSE RCM No.: 2014-25901.
`
`Reference ID: 3937130
`
`5
`
`

`

`2.2.6 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 6 names contained in Table 1 determined none of the names will pose a risk
`for confusion as described in Appendices C through H.
`
`2.2.7 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Gastroenterology and Inborn Error
`Products (DGIEP) via e-mail on May 6, 2016. At that time we also requested additional
`information or concerns that could inform our review. DGIEP did not state additional concerns
`with the proposed proprietary name.
`
`CONCLUSIONS
`3
`The proposed proprietary name is acceptable.
`If you have further questions or need clarifications, please contact please contact Aleksander
`Winiarski at 301-796-5295.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Yosprala, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your March 14, 2016, submission are
`altered prior to approval of the marketing application, the name must be resubmitted for
`review.
`
`Reference ID: 3937130
`
`6
`
`

`

`4
`
`REFERENCES
`
`1. USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical-science/united-
`states-adopted-names-council/naming-guidelines/approved-stems.page)
`USAN Stems List contains all the recognized USAN stems.
`
`2. Phonetic and Orthographic Computer Analysis (POCA)
`POCA is a system that FDA designed. As part of the name similarity assessment, POCA is used to
`evaluate proposed names via a phonetic and orthographic algorithm. The proposed proprietary name is
`converted into its phonemic representation before it runs through the phonetic algorithm. Likewise, an
`orthographic algorithm exists that operates in a similar fashion. POCA is publicly accessible.
`Drugs@FDA
`Drugs@FDA is an FDA Web site that contains most of the drug products approved in the United States
`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 and generic drugs; therapeutic biological products, prescription and over-the-
`counter human drugs; and discontinued drugs (see Drugs @ FDA Glossary of Terms, available at
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#ther biological).
`
`RxNorm
`
`RxNorm contains the names of prescription and many OTC drugs available in the United States. RxNorm
`includes generic and branded:
`
`
`
`Clinical drugs – pharmaceutical products given to (or taken by) a patient with therapeutic or
`diagnostic intent
` Drug packs – packs that contain multiple drugs, or drugs designed to be administered in a
`specified sequence
`
`Radiopharmaceuticals, contrast media, food, dietary supplements, and medical devices, such as
`bandages and crutches, are all out of scope for RxNorm
`(http://www.nlm.nih.gov/research/umls/rxnorm/overview.html#).
`
`Division of Medication Errors Prevention and Analysis proprietary name consultation 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.
`
`Reference ID: 3937130
`
`7
`
`

`

`APPENDICES
`
`Appendix A
`
`FDA’s Proprietary Name Risk Assessment evaluates proposed proprietary names for misbranding and safety concerns.
`
`1. Misbranding Assessment: For prescription drug products, OPDP assesses the name for misbranding concerns. . For over-the-
`counter (OTC) drug products, the misbranding assessment of the proposed name is conducted by DNCE. OPDP or DNCE evaluates
`proposed proprietary names to determine if the name is false or misleading, such as by making misrepresentations with respect to
`safety or efficacy. For example, a fanciful proprietary name may misbrand a product by suggesting that it has some unique
`effectiveness or composition when it does not (21 CFR 201.10(c) (3)). OPDP or DNCE provides their opinion to DMEPA for
`consideration in the overall acceptability of the proposed proprietary name.
`
`2.
`
`a.
`
`Safety Assessment: The safety assessment is conducted by DMEPA, and includes the following:
`
`Preliminary Assessment: We consider inclusion of USAN stems or other characteristics that when incorporated into a proprietary
`name may cause or contribute to medication errors (i.e., dosing interval, dosage form/route of administration, medical or product
`name abbreviations, names that include or suggest the composition of the drug product, etc.) See prescreening checklist below in
`Table 2*. 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. 6
`
`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Answer the questions in the checklist below. Affirmative answers to any of these questions
`indicate a potential area of concern that should be carefully evaluated as described in this
`guidance.
`
`Y/N
`
`Is the proposed name obviously similar in spelling and pronunciation to other names?
`
`Proprietary names should not be similar in spelling or pronunciation to proprietary names, established names, or
`ingredients of other products.
`
`Y/N
`
`Are there medical and/or coined abbreviations in the proprietary name?
`
`Proprietary names should not incorporate medical abbreviations (e.g., QD, BID, or others commonly used for
`prescription communication) or coined abbreviations that have no established meaning.
`
`Y/N
`
`Are there inert or inactive ingredients referenced in the proprietary name?
`
`Proprietary names should not incorporate any reference to an inert or inactive ingredient in a way that might create
`an impression that the ingredient’s value is greater than its true functional role in the formulation (21 CFR 201.10(c)
`(4)).
`
`Y/N
`
`Does the proprietary name include combinations of active ingredients?
`
`Y/N
`
`Y/N
`
`Proprietary names of fixed combination drug products should not include or suggest the name of one or more, but
`not all, of its active ingredients (see 21 CFR 201.6(b)).
`
`Is there a United States Adopted Name (USAN) stem in the proprietary name?
`
`Proprietary names should not incorporate a USAN stem in the position that USAN designates for the stem.
`
`Is this proprietary name used for another product that does not share at least one common active ingredient?
`
`Drug products that do not contain at least one common active ingredient should not use the same (root) proprietary
`name.
`
`Y/N
`
`Is this a proprietary name of a discontinued product?
`
`Proprietary names should not use the proprietary name of a discontinued product if that discontinued drug product
`does not contain the same active ingredients.
`
`b.
`
`Phonetic and Orthographic Computer Analysis (POCA): Following the preliminary screening of the proposed proprietary name,
`DMEPA staff evaluates the proposed name against potentially similar names. In order to identify names with potential similarity to
`
`6 National Coordinating Council for Medication Error Reporting and Prevention. http://www.nccmerp.org/aboutMedErrors.html. Last accessed
`10/11/2007.
`
`Reference ID: 3937130
`
`8
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`

`

`the proposed proprietary name, DMEPA enters the proposed proprietary name in POCA and queries the name against the following
`drug reference databases, Drugs@fda, CernerRxNorm, and names in the review pipeline using a 50% threshold in POCA. DMEPA
`reviews the combined orthographic and phonetic matches and group the names into one of the following three categories:
`
`•
`
`•
`
`•
`
`Highly similar pair: combined match percentage score ≥70%.
`
`Moderately similar pair: combined match percentage score ≥50% to ≤ 69%.
`
`Low similarity: combined match percentage score ≤49%.
`
`Using the criteria outlined in the check list (Table 3-5) that corresponds to each of the three categories (highly similar pair, moderately
`similar pair, and low similarity), DMEPA evaluates the name pairs to determine the acceptability or non-acceptability of a proposed
`proprietary name. The intent of these checklists is to increase the transparency and predictability of the safety determination of whether
`a proposed name is vulnerable to confusion from a look-alike or sound-alike perspective. Each bullet below corresponds to the name
`similarity category cross-references the respective table that addresses criteria that DMEPA uses to determine whether a name presents a
`safety concern from a look-alike or sound-alike perspective.
`
`For highly similar names, differences in product characteristics often cannot mitigate the risk of a medication error, including
`product differences such as strength and dose. Thus, proposed proprietary names that have a combined score of ≥ 70 percent are at
`risk for a look-alike sound-alike confusion which is an area of concern (See Table 3).
`Moderately similar names with overlapping or similar strengths or doses represent an area for concern for FDA. The dosage and
`strength information is often located in close proximity to the drug name itself on prescriptions and medication orders, and it can be
`an important factor that either increases or decreases the potential for confusion between similarly named drug pairs. The ability of
`other product characteristics to mitigate confusion (e.g., route, frequency, dosage form, etc.) may be limited when the strength or
`dose overlaps. We review such names further, to determine whether sufficient differences exist to prevent confusion. (See Table
`4).
`Names with low similarity that have no overlap or similarity in strength and dose are generally acceptable (See Table 5) unless there
`are data to suggest that the name might be vulnerable to confusion (e.g., prescription simulation study suggests that the name is
`likely to be misinterpreted as a marketed product). In these instances, we would reassign a low similarity name to the moderate
`similarity category and review according to the moderately similar name pair checklist.
`
`
`
`
`
`c.
`
`FDA Prescription Simulation Studies: DMEPA staff also conducts a prescription simulation studies using FDA health care professionals.
`
`Three separate studies are conducted within the Centers of the FDA for the proposed proprietary name to determine the degree of
`confusion of the proposed proprietary name with marketed U.S. drug names (proprietary and established) due to similarity in visual
`appearance with handwritten prescriptions or verbal pronunciation of the drug name. The studies employ healthcare professionals
`(pharmacists, physicians, and nurses), and attempts to simulate the prescription ordering process. The primary Safety Evaluator uses the
`results to identify orthographic or phonetic vulnerability of the proposed name to be misinterpreted by healthcare practitioners.
`
`In order to evaluate the potential for misinterpretation of the proposed proprietary name in handwriting and verbal communication of
`the name, inpatient medication orders and/or outpatient prescriptions are written, each consisting of a combination of marketed and
`unapproved drug products, including the proposed name. These orders are optically scanned and one prescription is delivered to a
`random sample of 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 record their interpretations of the orders which are recorded
`electronically.
`
`d.
`
`Comments from Other Review Disciplines: DMEPA requests the Office of New Drugs (OND) and/or Office of Generic Drugs (OGD), ONDQA
`or OBP for their comments or concerns with the proposed proprietary name, ask for any clinical issues that may impact the DMEPA review
`during the initial phase of the name review. Additionally, when applicable, at the same time DMEPA requests concurrence/non-
`concurrence with OPDP’s decision on the name. The primary Safety Evaluator addresses any comments or concerns in the safety
`evaluator’s assessment.
`
`The OND/OGD Regulatory Division is contacted a second time following our analysis of the proposed proprietary name. At this point,
`DMEPA conveys their decision to accept or reject the name. The OND or OGD Regulatory Division is requested to provide any further
`information that might inform DMEPA’s final decision on the proposed name.
`
`Additionally, other review disciplines opinions such as ONDQA or OBP may be considered depending on the proposed proprietary name.
`
`When provided, DMEPA considers external proprietary name studies conducted by or for the Applicant/Sponsor and incorporates the findings
`of these studies into the overall risk assessment.
`
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name is responsible for considering the collective findings, and
`provides an overall risk assessment of the proposed proprietary name.
`
`Table 3. Highly Similar Name Pair Checklist (i.e., combined Orthographic and Phonetic score is ≥ 70%).
`Answer the questions in the checklist below. Affirmative answers to some of these questions suggest that the pattern of
`orthographic or phonetic differences in the names may render the names less likely to confusion, provided that the pair do
`not share a common strength or dose.
`
`Reference ID: 3937130
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`9
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`

`

`Orthographic Checklist
`
`Phonetic Checklist
`
`Y/N
`
`Do the names begin with different first letters?
`Note that even when names begin with
`different first letters, certain letters may be
`confused with each other when scripted.
`
`Y/N
`
`Do the names have different number of
`syllables?
`
`Y/N
`
`Y/N
`
`Y/N
`
`Do the names have different syllabic
`stresses?
`
`Do the syllables have different
`phonologic processes, such vowel
`reduction, assimilation, or deletion?
`
`Across a range of dialects, are the names
`consistently pronounced differently?
`
`Y/N
`
`Are the lengths of the names dissimilar* when
`scripted?
`
`*FDA considers the length of names different if
`the names differ by two or more letters.
`
`Considering variations in scripting of some
`letters (such as z and f), is there a different
`number or placement of upstroke/downstroke
`letters present in the names?
`
`Is there different number or placement of
`cross-stroke or dotted letters present in the
`names?
`
`Do the infixes of the name appear dissimilar
`when scripted?
`
`Do the suffixes of the names appear dissimilar
`when scripted?
`
`Y/N
`
`Y/N
`
`Y/N
`
`Y/N
`
`Table 4: Moderately Similar Name Pair Checklist (i.e., combined score is ≥50% to ≤69%).
`
`Step 1
`
`Review the DOSAGE AND ADMINISTRATION and HOW SUPPLIED/STORAGE AND HANDLING sections of the prescribing
`information (or for OTC drugs refer to the Drug Facts label) to determine if strengths and doses of the name pair
`overlap or are very similar. Different strengths and doses for products whose names are moderately similar may
`decrease the risk of confusion between the moderately similar name pairs. Name pairs that have overlapping or similar
`strengths or doses have a higher potential for confusion and should be evaluated further (see Step 2). Because the
`strength or dose could be used to express an order or prescription for a particular drug product, overlap in one or both
`of these components would be reason for further evaluation.
`
`For single strength products, also consider circumstances where the strength may not be expressed.
`
`For any i.e. drug products comprised of more than one active ingredient, consider whether the strength or dose may be
`expressed using only one of the components.
`
`To determine whether the strengths or doses are similar to your proposed product, consider the following list of factors
`that may increase confusion:
`
`oAlternative expressions of dose: 5 mL may be listed in the prescribing information, but the dose may be
`
`Reference ID: 3937130
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`10
`
`

`

`expressed in metric weight (e.g., 500 mg) or in non-metric units (e.g., 1 tsp, 1 tablet/capsule). Similarly,
`a strength or dose of 1000 mg may be expressed, in practice, as 1 g, or vice versa.
`
`oTrailing or deleting zeros: 10 mg is similar in appearance to 100 mg which may potentiate confusion between
`a name pair with moderate similarity.
`oSimilar sounding doses: 15 mg is similar in sound to 50 mg
`
`Step 2
`
`Answer the questions in the checklist below. Affirmative answers to some of these questions suggest that the pattern
`of orthographic or phonetic differences in the names may reduce the likelihood of confusion for moderately similar
`names with overlapping or similar strengths or doses.
`
`Orthographic Checklist (Y/N to each question)
`
`Do the names begin with different first letters?
`
`Phonetic Checklist (Y/N to each question)
`
`Do the names have different number of
`syllables?
`
`
`
`
`
`
`
`Do the names have different syllabic stresses?
`
`Do the syllables have different phonologic
`processes, such vowel reduction, assimilation,
`or deletion?
`
`Across a range of dialects, are the names
`consistently pronounced differently?
`
`Note that even when names begin with
`different first letters, certain letters may be
`confused with each other when scripted.
`
`Are the lengths of the names dissimilar* when
`scripted?
`
`*FDA considers the length of names different if
`the names differ by two or more letters.
`
`Considering variations in scripting of some
`letters (such as z and f), is there a different
`number or placement of upstroke/downstroke
`letters present in the names?
`
`Is there different number or placement of
`cross-stroke or dotted letters present in the
`names?
`
`Do the infixes of the name appear dissimilar
`when scripted?
`
`Do the suffixes of the names appear dissimilar
`when scripted?
`
`
`
`
`
`
`
`
`
`
`
`Table 5: Low Similarity Name Pair Checklist (i.e., combined score is ≤49%).
`
`In most circumstances, these names are viewed as sufficiently different to minimize confusion. Exceptions to this would occur in
`circumstances where, for example, there are data that suggest a name with low similarity is nonetheless misinterpreted as a
`marketed product name in a prescription simulation study. In such instances, FDA would reassign a low similarity name to the
`moderate similarity category and review according to the moderately similar name pair checklist.
`
`Reference ID: 3937130
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`11
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`

`

`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Yosprala Study (Conducted on April 18, 2016)
`
`Handwritten Requisition Medication Order
`Medication Order:
`
`Verbal Prescription
`Yosprala 325 mg/40 mg
`# 30
`1 tab po once daily
`
`Outpatient Prescription:
`
`Reference ID: 3937130
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`12
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`

`

`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)
`
`
`296 People Received Study
`74 People Responded
`
`Study Name: Yosprala
`Total
`
`27
`
`21
`
`26
`
`
`
`INTERPRETATION
`
`OUTPATIENT
`
`VOICE
`
`INPATIENT
`
`TOTAL
`
`URSPRALA
`
`YASPRALA
`
`YESBRALA
`
`YESPRALA
`
`YORPASALA
`
`YOSFLARA
`
`YOSPRALA
`
`YOSPRALEN
`
`YOSPRALER
`
`YOSPRALLA
`
`YOSPROULA
`
`YOSPROWLA
`
`YSOPRALA
`
`YUSPRAWLA
`
`ZOSPALA
`
`0
`
`6
`
`0
`
`6
`
`1
`
`0
`
`14
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`1
`
`0
`
`0
`
`1
`
`11
`
`0
`
`0
`
`3
`
`1
`
`1
`
`0
`
`1
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`7
`
`4
`
`14
`
`0
`
`0
`
`0
`
`1
`
`0
`
`0
`
`1
`
`6
`
`1
`
`6
`
`1
`
`1
`
`32
`
`4
`
`14
`
`3
`
`1
`
`1
`
`1
`
`1
`
`1
`
`Reference ID: 3937130
`
`13
`
`

`

`Appendix C: Highly Similar Names (e.g., combined POCA score is ≥70%)
`
`No.
`
`1.
`
`Proposed name: Yosprala
`Strengths:
`81 mg delayed release
`aspirin/40 mg immediate
`release omeprazole
`325 mg delayed release
`aspirin/40 mg immediate
`release omeprazole
`Usual Dose: One tablet once
`daily
`Yosprala
`
`POCA
`Score (%)
`
`Orthographic and/or phonetic differences in the
`names sufficient to prevent confusion
`
`100
`
`Proposed proprietary name subject of this review.
`
`Appendix D: Moderately Similar Names (e.g., combined POCA score is ≥50% to ≤69%) with no
`overlap or numerical similarity in Strength and/or Dose
`
`No.
`
`Proposed Name
`
`1.
`
`Lidotral
`
`POCA Score
`(%)
`
`51
`
`Appendix E: Moderately Similar Names (e.g., combined POCA score is ≥50% to ≤69%) with
`overlap or numerical similarity in Strength and/or Dose – N/A
`
`Appendix F: Low Similarity Names (e.g., combined POCA score is ≤49%)-N/A
`
`Appendix G: Names not likely to be confused or not used in usual practice settings for the
`reasons described.
`
`No.
`
`Name
`
`***
`
`1.
`
`2.
`
`POCA
`Score (%)
`60
`
`Failure preventions
`
`Proposed proprietary name found
`unacceptable by DMEPA (OSE#
`). Product is conditionally approved
`under new proprietary name
`***.
`Proprietary name was withdrawn
`
` Name
`
`***
`
`60
`
`Reference ID: 3937130
`
`14
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`would be resubmitted for review before it
`can be approved.
`
`Appendix H: Names not likely to be confused due to notable spelling, orthographic and
`phonetic differences.
`
`No.
`
`1.
`2.
`
`Proposed Name
`
`Spinraza***
`***
`
`POCA Score
`(%)
`56
`50
`
`Appendix I: Names identified in the eDRLS database not likely to be confused due to notable
`spelling, orthographic and phonetic differences- N/A
`
`Reference ID: 3937130
`
`15
`
`(b) (4)
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SHERLY ABRAHAM
`05/26/2016
`
`MISHALE P MISTRY
`05/27/2016
`
`Reference ID: 3937130
`
`

`

`PROPRIETARY NAME REVIEW
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the public***
`
`Date of This Review:
`September 29, 2014
`Application Type and Number: NDA 205103
`Product Name and Strength:
`Yosprala (Aspirin and Omeprazole)
`Delayed-release Tablets
`325 mg/40 mg and 81 mg/40 mg
`Multi Ingredient
`Rx
`Pozen Inc.
`July 21, 2014
`2014-25901
`Sherly Abraham, R.Ph
`Kendra Worthy, Pharm.D.
`Lubna Merchant, M.S., Pharm.D.
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`DMEPA Associate Director:
`
`Reference ID: 3636800
`
`

`

`1
`
`Contents
`INTRODUCTION ........................................................................................................... 1
`1.1
`Regulatory History................................................................................................ 1
`1.2
`Product Information............................................................................................. 1
`RESULTS ....................................................................................................................... 2
`2.1 Misbranding Assessment ..................................................................................... 2
`2.2
`Safety Assessment................................................................................................ 2
`CONCLUSIONS.............................................................................................................. 3
`3.1
`Comments to the Applicant ................................................................................. 3
`REFERENCES............................................................................................