CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`022501Orig1s000
`
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`Date:
`
`October 8, 2010
`
`Application Type/Number: NDA 022501
`
`To:
`
`Through:
`
`From:
`
`Subject:
`
`Drug Name(s):
`
`Scott Monroe, M.D., Director
`Division of Reproductive and Urologic Products
`
`Zachary Oleszczuk, Pharm.D., Team Leader
`Denise Toyer, Pharm.D., Deputy Director
`Division of Medication Error Prevention and Analysis
`
`Tara Turner, Pharm.D., Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`Proprietary Name, Label and Labeling Review
`
`Lo Loestrin Fe
`(Norethindrone Acetate and Ethinyl Estradiol Tablets, 1 mg/10 mcg
`Ethinyl Estradiol Tablets, 10 mcg and Ferrous Fumarate Tablets,
`75 mg)
`
`Applicant:
`
`OSE RCM #:
`
`Warner Chilcott
`
`2010-1184 and 2009-652
`
`
`
`
`
`
`
`

`

`CONTENTS
`INTRODUCTION................................................................................................................... 3
`1
`2 METHODS AND RESULTS.................................................................................................. 3
`2.1
`Proprietary Name ........................................................................................................... 3
`2.2
`Labels and Labeling....................................................................................................... 3
`3 DISCUSSION ......................................................................................................................... 3
`3.1
`Proprietary Name ........................................................................................................... 3
`3.2
`Labels and Labeling....................................................................................................... 4
`4 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 4
`4.1
`Proprietary Name ........................................................................................................... 4
`4.2
`Labels and Labeling....................................................................................................... 4
`REFERENCES................................................................................................................................ 6
`APPENDICES................................................................................................................................. 7
`
`
`
`
`
`2
`
`

`

`1
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Lo Loestrin Fe, is written in response to the anticipated
`approval of this NDA within 90 days from the date of this review. DMEPA found the proposed name, Lo
`Loestrin Fe, acceptable in OSE Review #2009-2349, dated January 19, 2010. DDMAC reviewed the proposed
`name on December 17, 2009, and had no concerns regarding the proposed name from a promotional
`perspective. Furthermore, the Review Division did not have any concerns with the proposed name, Lo Loestrin
`Fe, during our initial review.
`The Applicant received a complete response action for this NDA on January 26, 2010. The Applicant
`submitted a class 2 response on April 21, 2010. As part of that response, the Applicant submitted revised
`container labels, carton and insert labeling, which are also the subject of the current review. During the initial
`review cycle of this NDA, DMEPA completed a review of the Applicant’s proposed labels and labeling in OSE
`Review #2009-652, dated January 14, 2010.
`
`2 METHODS AND RESULTS
`
`2.1 PROPRIETARY NAME
`For the proposed proprietary name, DMEPA staff search a standard set of databases and information sources
`(see section 4) to identify names with orthographic and phonetic similarity to the proposed name that have been
`approved since the previous OSE proprietary name review. We used the same search criteria used in OSE
`Review #2009-2349 for the proposed proprietary name, Lo Loestrin Fe. Since none of the proposed product
`characteristics were altered we did not re-evaluate previous names of concern.
`Additionally, DMEPA searched the United States Adopted Names (USAN) stem list to determine if the name
`contains any USAN stems as of the last USAN update. DMEPA bases the overall risk assessment on the
`findings of a Failure Mode and Effects Analysis (FMEA) of the proposed proprietary name, and focuses on the
`avoidance of medication errors. As in the previous proprietary name review, DMEPA staff identified a United
`States Adopted Names (USAN) stem in the proposed proprietary name, as of October 4, 2010. The stem is
`-estr-, which represents estrogens.
`The searches of the databases yielded no new names thought to look or sound similar to Lo Loestrin Fe and
`represent a potential source of drug name confusion.
`
`2.2 LABELS AND LABELING
`The Applicant submitted revised container labels (see Appendix A), carton (see Appendix B), and insert
`labeling on April 21, 2010. DMEPA used Failure Mode and Effects Analysis (FMEA) and the principles of
`Human Factors in our evaluation of the labels and labeling. We also reviewed the labeling recommendations
`presented in OSE Review #2009-652, dated January 14, 2010 to determine if our recommendations had been
`incorporated into the revised labels and labeling.
`
`3 DISCUSSION
`
`3.1 PROPRIETARY NAME
`As noted in the previous proprietary name review of Lo Loestrin Fe, the root name, Loestrin, contains the
`USAN stem -estr-, which represents estrogens. Inclusion of a USAN stem in a proprietary name is typically
`unacceptable. However, in this case since the root name was approved in 1973, the presence of the USAN
`stem alone would not render the name unacceptable.
`
`
`
`3
`
`

`

`3.2 LABELS AND LABELING
`The Applicant revised the labels and labeling and incorporated most of DMEPA’s recommendations.
`However, changes in the presentation of the proprietary name and the product strength pose additional
`concerns.
`
`4 CONCLUSIONS AND RECOMMENDATIONS
`
`4.1 PROPRIETARY NAME
`This re-review determined that the proposed name, Lo Loestrin Fe, is not vulnerable to name confusion that
`could lead to medication errors, nor is the name considered promotional. Thus, the Division of Medication
`Error Prevention and Analysis (DMEPA) has no objection to the proprietary name, Lo Loestrin Fe, for this
`product at this time.
`
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days from the
`date of this review, the Division of Reproductive and Urologic Products should notify DMEPA because the
`proprietary name must be re-reviewed prior to the new approval date.
`
`4.2 LABELS AND LABELING
`Our evaluation noted areas where the presentation of information on the container labels, carton and insert
`labeling can be improved to minimize the potential for medication errors. We provide recommendations for all
`product labels and labeling in Section 4.2.1 Comments to the Division for discussion during the review team’s
`label and labeling meetings. Section 4.2.2 Comments to the Applicant contains our recommendations for the
`container labels and carton labeling. We request the recommendations in Section 4.2.2 be communicated to the
`Applicant prior to approval.
`Please copy the Division of Medication Error Prevention and Analysis on any communication to the Applicant
`with regard to this review. If you have further questions or need clarifications on this review, please contact
`Maria Wasilik, Project Manager, at 301-796-0567.
`
`4.2.1 Comments to the Division
`A. General Comments for All Labels and Labeling
`1. As stated in our previous review, we defer to the clinical review team for a decision regarding
`inclusion of the statement “Lo Loestrin Fe provides 26 days of active therapy” since it is unclear
`whether the 2 tablets containing ethinyl estradiol alone provide oral contraceptive efficacy. If the
`statement is included, it should be presented with less prominence than the proprietary name,
`established name, and product strength.
`2. Consider revising the font used to present the proprietary name. As currently presented, the font is
`fanciful and may be difficult to read, especially the capital letter ‘F’, which may be confused as a
`capital letter ‘T’.
`
`4.2.2 Comments to the Applicant
`A. Container Labels: Blister Card: Trade and Sample (28 tablets)
`1. Remove the
` separating the proprietary name from the established name
`as this line is considered intervening matter and violates 21 CFR 201.10(a).
`2. Increase the prominence of the proprietary name. As currently presented, it has less prominence
`than the manufacturer’s logo.
`
`
`
`4
`
`(b) (4)
`
`

`

`3. Present the product strength on the blister card. As currently presented, the strength is missing.
`B. Carton Labeling: Trade (5 blister cards per carton); Sample (1 blister card per carton; 6 cartons
`per tray)
`1. Remove the
`” separating the proprietary name from the established name
`as this line is considered intervening matter and violates 21 CFR 201.10(a).
`2. On the trade carton, relocate the statement “Ferrous fumarate tablets are not USP for dissolution
`and assay” (located in the upper left-hand corner of the principal display panel) to the back panel.
`As currently presented, this information is extraneous.
`3. Present the product strength immediately after the established name on the principal display panel.
`As currently presented, the strength is only located on a side panel.
`
`
`
`
`5
`
`(b) (4)
`
`

`

`REFERENCES
`OSE Review #2009-2349 Lo Loestrin Fe Proprietary Name Review, January 19, 2010,
`1.
`Turner, Tara.
` OSE Review #2009-652, Lo Loestrin Fe Label and Labeling Review, January 14, 2010,
`Turner, Tara.
`
`2.
`
`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`3.
`Drugs@FDA contains most of the drug products approved since 1939. The majority of labels, approval letters,
`reviews, and other information are available for drug products approved from 1998 to the present.
`Drugs@FDA contains official information about FDA approved brand name, generic drugs, therapeutic
`biological products, prescription and over-the-counter human drugs and discontinued drugs and “Chemical
`Type 6” approvals.
`
`USAN Stems (http://www.ama-assn.org/ama/pub/category/4782.html)
`4.
`USAN Stems List contains all the recognized USAN stems.
`
`Division of Medication Error Prevention and Analysis Proprietary Name Consultation Request
`5.
`Compiled list of proposed proprietary names submitted to the Division of Medication Error Prevention and
`Analysis for review. The list is generated on a weekly basis from the Access database/tracking system.
`
`
`
`6
`
`5 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/
`TS) immediately following this page
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`TARA P TURNER
`10/08/2010
`
`ZACHARY A OLESZCZUK
`10/08/2010
`
`DENISE P TOYER
`10/08/2010
`
`Reference ID: 2847855
`
`

`

`
`
`Date:
`
`To:
`
`Through:
`
`From:
`
`Subject:
`
`Drug Name(s):
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`January 19, 2010
`
`Scott Monroe, M.D., Director
`Division of Reproductive and Urologic Products
`
`Zachary Oleszczuk, Pharm.D., Acting Team Leader
`Kellie Taylor, Pharm.D., MPH, Associate Director
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis
`
`Tara Turner, Pharm.D., Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`Proprietary Name Review
`
`Lo Loestrin Fe
`(Norethindrone Acetate 1 mg and Ethinyl Estradiol 10 mcg tablets,
`Ethinyl Estradiol 10 mcg tablets, and Ferrous Fumarate 75 mg
`Tablets)
`
`Application Type/Number: NDA # 022501
`
`Applicant:
`
`OSE RCM #:
`
`Warner Chilcott
`
`2009-2349
`
`
`*** 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
`Regulatory History......................................................................................................... 3
`1.3
`Product Information....................................................................................................... 3
`1.4
`Applicant’s Rationale for Proposed Name..................................................................... 4
`2 METHODS AND MATERIALS ............................................................................................ 4
`2.1
`Search Criteria................................................................................................................ 4
`2.2
`FDA Prescription Analysis Studies................................................................................ 5
`3 RESULTS................................................................................................................................ 5
`3.1
`Database and Information Sources................................................................................. 5
`3.2
`CDER Expert Panel Discussion..................................................................................... 6
`3.3
`FDA Prescription Analysis Studies................................................................................ 6
`3.4
`Comments from the Division of Reproductive and Urologic Products (DRUP)........... 6
`3.5
`Safety Evaluator Risk Assessment................................................................................. 6
`4 DISCUSSION ......................................................................................................................... 7
`4.1
`Use of “Lo” and “Fe” Modifiers.................................................................................... 7
`4.2
`Analysis of Root Name “Loestrin” ................................................................................ 8
`5 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 8
`5.1
`Comments to the Applicant............................................................................................ 8
`6 REFERENCES........................................................................................................................ 9
`APPENDICES............................................................................................................................... 11
`
`
`
`
`
`2
`
`

`

`EXECUTIVE SUMMARY
`Lo Loestrin Fe is the proposed proprietary name for norethindrone acetate and ethinyl estradiol tablets,
`ethinyl estradiol tablets, and ferrous fumarate tablets. This product represents an extension of the current
`Loestrin product line. This proposed name was evaluated from a safety and promotional perspective
`based on the product characteristics provided by the Applicant. We sought input from pertinent
`disciplines involved with the review of this application and considered it accordingly. Our evaluation did
`not identify concerns that would render the name unacceptable based on the product characteristics and
`safety profile known at the time of this review. Thus, DMEPA finds the proposed proprietary name, Lo
`Loestrin Fe, acceptable for this product. The proposed proprietary name must be re-reviewed 90 days
`before approval of the NDA.
`Additionally, if any of the proposed product characteristics as stated in this review are altered, DMEPA
`rescinds this finding and the name must be resubmitted for review. The conclusions upon re-review are
`subject to change.
`
`1 BACKGROUND
`
`1.1
`INTRODUCTION
`This review is in response to a request from Warner Chilcott dated November 30, 2009 for an assessment
`of the proposed proprietary name, Lo Loestrin Fe, regarding potential name confusion with other
`proprietary or established drug names in the usual practice settings. The Applicant also submitted draft
`container labels, carton and insert labeling, which will be evaluated in a separate DMEPA review (see
`OSE RCM# 2009-652).
`
`1.2 REGULATORY HISTORY
` as the proposed proprietary name for this
`On April 9, 2009, the Applicant submitted
`product. The Division of Medication Error Prevention and Analysis (DMEPA) found the proposed name
`unacceptable because it does not provide adequate distinction from other combination products in the
`Loestrin product line. Subsequently, on September 21, 2009, the Applicant submitted
` which was determined by DMEPA to contain ambiguous modifiers. This information was
`communicated to the Applicant via teleconference on November 2, 2009 and the name was withdrawn.
`On November 11, 2009, the Applicant submitted
` which was determined by DMEPA to
`contain the USAN stem –estr-. This information was communicated to the Applicant via telephone call
`and the name was withdrawn. On November 30, 2009, the proposed proprietary name “Lo Loestrin Fe”
`was submitted and is the subject of the current review.
`
`
`
`1.3 PRODUCT INFORMATION
`Lo Loestrin Fe is indicated for the prevention of pregnancy in women
` The dosage of Lo Loestrin Fe is one blue tablet containing norethindrone
`acetate 1 mg and ethinyl estradiol 10 mcg daily for 24 consecutive days, followed by one white tablet
`containing ethinyl estradiol 10 mcg daily for 2 consecutive days, followed by one brown non-hormonal
`(placebo) tablet containing ferrous fumarate 75 mg daily for 2 consecutive days. The ferrous fumarate
`tablets do not serve any therapeutic purpose. All the tablets should be taken exactly as directed and at
`intervals not exceeding 24 hours. A patient should begin to take this product
` on the first day of her
`menstrual period (Day 1 Start)
`
` The product is supplied in cartons containing 5 blister cards (dispensers) of a 28-day regimen.
`
`
`
`
`
`3
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`1.4 APPLICANT’S RATIONALE FOR PROPOSED NAME
`In their proprietary name submission, the Applicant cites the following rationale for use of the proposed
`modifiers:
`The modifier ‘Lo’ denotes the low amount of estrogen in this product when compared with other
`approved Loestrin products; the name Lo Loestrin Fe would accurately represent the fact that the
`new product provides the lowest estrogen regimen of all Loestrin products in the market. The
`modifier ‘Fe’ denotes the ferrous fumarate tablets (non-hormonal) provided to complete a 28-day
`cycle.
`
`2 METHODS AND MATERIALS
`Appendix A describes the general methods and materials used by the Division of Medication Error
`Prevention and Analysis (DMEPA) when conducting a proprietary name risk assessment for all
`proprietary names. Sections 2.1 and 2.2 identify specific information associated with the methodology
`for the proposed proprietary name, Lo Loestrin Fe.
`
`2.1 SEARCH CRITERIA
`For this review, particular consideration was given to drug names beginning with the letter ‘L’ 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.1,2
`To identify drug names that may look similar to Lo Loestrin Fe, the DMEPA staff also considers the
`orthographic appearance of the name on lined and unlined orders. In this case, we evaluated the root
`name ‘Loestrin’ separately and in conjunction with the additional descriptor segments of the name (‘Lo’
`and ‘Fe’): ‘Lo’ denotes the low amount of estrogen in this product compared to other approved Loestrin
`products. ‘Lo’ is used for other marketed oral contraceptive products (and in some proposed names) to
`describe lower estrogen content, lower estrogen and progestin content, or lower dose in general (see
`Appendices D and E). For these uses, it is placed at the beginning, in the middle, or at the end of the
`proprietary name. ‘Fe’ is used to describe the non-hormonal component (i.e. ferrous fumarate) and is
`commonly used within the Loestrin product line (see Appendix F) and for other oral contraceptive
`products.
`Specific attributes taken into consideration include the length of the name (twelve letters; three words),
`upstrokes (four: two capital letters ‘L’, capital letter ‘F’, and lower case ‘t’), downstrokes (none), cross-
`strokes (two: lower case ‘t’ and capital letter ‘F’) and dotted letters (one, lower case ‘i’). Additionally,
`several letters in Lo Loestrin Fe may be vulnerable to ambiguity when scripted (see Appendix B). As a
`result, the DMEPA staff also considers these alternate appearances when identifying drug names that may
`look similar to Lo Loestrin Fe.
`When searching to identify potential names that may sound similar to Lo Loestrin Fe, the DMEPA staff
`searches for names with similar number of syllables (6), stresses ( LO lo-ES- trin ef- e or LO lo-es-TRIN
`ef- e or LO LO-es-trin ef- e), and placement of vowel and consonant sounds. Additionally, the DMEPA
`staff considers that pronunciation of parts of the name can vary (see Appendix B). The Applicant’s
`intended pronunciation (lō lō-ĕs’trĭn ĕf-ē) was also taken into consideration, as it was included in the
`
`1 Institute for Safe Medication Practices. Confused Drug name List (1996-2006). Available at
`http://www.ismp.org/Tools/confuseddrugnames.pdf
`2 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artificial Intelligence in
`Medicine (2005)
`
`4
`
`

`

`Proprietary Name Review Request. However, names are often mispronounced and/or spoken with
`regional accents and dialects, so other potential pronunciations of the name are considered.
`
`2.2 FDA PRESCRIPTION ANALYSIS STUDIES
`In order to evaluate the potential for misinterpretation of the proposed proprietary name in handwriting
`and verbal communication of the name, the following inpatient medication order, outpatient and verbal
`prescription was communicated during the FDA prescription studies.
`
`VERBAL
`PRESCRIPTION
`
`
`“Lo Loestrin Fe
`1 tab PO daily”
`
`Figure 1. Lo Loestrin Fe Study (conducted on December 17, 2009)
`
`HANDWRITTEN PRESCRIPITON AND MEDICATION ORDER
`
`Inpatient Medication Order:
`
`Outpatient Prescription:
`
`
`
`3 RESULTS
`
`
`
`
`
`
`
`3.1 DATABASE AND INFORMATION SOURCES
`The searches yielded a total of 26 names as having some similarity to the proposed proprietary name, Lo
`Loestrin Fe.
`Ten of the names were thought to look like Lo Loestrin Fe (Halotestin, Colocort, Lo Ovral, Norlestrin 21
`1/50, Norlestrin 21 2.5/50, Norlestrin 28 1/50, Norlestrin Fe 1/50, Norlestrin Fe 2.5/50, Lotensin, and
`Clobetasol). One name (Elestrin) was thought to sound like Lo Loestrin Fe. The remaining fifteen names
`(Loestrin 24, Loestrin 24 Fe, Loestrin,
` Loestrin Fe 1.5/30,
`Loestrin Fe 1/20, Loestrin Fe, Loestrin 1.5/30, Loestrin 1/20, Loestrin 21 1/20, Loestrin 21 1.5/30,
`Loestrin 21, Lo Estrin Fe 24, and Lo Estrin Fe) were thought to look and sound similar to Lo Loestrin Fe.
`Our searches also revealed that the proposed root name, Loestrin, is trademarked in the U.S. by Warner-
`Lambert Company and in several foreign countries by Parke Davis and Company, Galen Chemicals Ltd.,
`or Warner Chilcott Company, Inc.
`Additionally, DMEPA staff identified a United States Adopted Names (USAN) stem in the proposed
`proprietary name, as of December 17, 2009. The stem is –estr-, which represents estrogens.
`
`
`5
`
`(b) (4)
`
`

`

`3.2 CDER EXPERT PANEL DISCUSSION
`The Expert Panel reviewed the pool of names identified by DMEPA staff (See Section 3.1 above) and
`noted no additional names thought to have orthographic or phonetic similarity to Lo Loestrin Fe. The
`Expert Panel discussed the following concerns with the “Lo” modifier: “Lo” may be overlooked; what
`does “Lo” convey?; “Lo” can look like the number “10”; “Lo” may be interpreted as a stutter and omitted
`when transcribed from verbal orders; seems like a typographical error with double “Lo”.
`Additionally, the Expert Panel indicated that either of the modifiers (“Lo” or “Fe”) could be omitted from
`prescriptions or medication orders.
`Finally, the Expert Panel identified several definitions for the medical abbreviation “Lo”: lateral oblique,
`linguo-occlusal, low lumber orthosis, lenticular opacity, leucine oxidation, and loss.
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did not offer
`any additional comments relating to the proposed name.
`
`3.3 FDA PRESCRIPTION ANALYSIS STUDIES
`For the study conducted on December 17, 2009, a total of 25 practitioners responded but none of the
`responses overlapped with any existing or proposed drug names. Nine of the participants interpreted the
`drug name correctly as “Lo Loestrin Fe” or “Loloestrin Fe”, with the majority of correct interpretations
`occurring in the outpatient written study and the verbal study. The remainder of participants
`misinterpreted the drug name. Approximately half of the misinterpretations in the inpatient written study
`involved the transcription of the first letter as “Z” instead of “L” followed by various misspellings. See
`Appendix C for the complete listing of interpretations from the verbal and written prescription studies.
`
`3.4 COMMENTS FROM THE DIVISION OF REPRODUCTIVE AND UROLOGIC PRODUCTS (DRUP)
`
`3.4.1 Initial Phase of Review
`In a response to the OSE December 17, 2009 e-mail, the Division of Reproductive and Urologic Products
`(DRUP) indicated that they had no comments regarding the proposed proprietary name, Lo Loestrin Fe.
`
`3.4.2 Midpoint of Review
`On December 23, 2009, DMEPA notified the Division of Reproductive and Urologic Products (DRUP)
`via e-mail that we had no objections to the proposed proprietary name Lo Loestrin Fe. Per e-mail
`correspondence from the Division of Reproductive and Urologic Products on December 23, 2009, they
`indicated that they concur with our assessment of the proposed proprietary name, Lo Loestrin Fe.
`
`3.5 SAFETY EVALUATOR RISK ASSESSMENT
`Independent searches by the primary Safety Evaluator identified one additional name which was thought
`to look similar to Lo Loestrin Fe and represent a potential source of drug name confusion. That name is
`Loniten.
`
`Additionally, we note that two of the identified names (
`were proposed names for the product under review which were found unacceptable by DMEPA. Further,
`we note that eight of the identified names are variations of the approved Loestrin product line (Loestrin
`24, Loestrin, Loestrin Fe, Loestrin 1.5/30, Loestrin 1/20, Loestrin 21, Lo Estrin Fe 24, and Lo Estrin Fe).
`We assume that these names were reported incorrectly during the search process. They are already
`accounted for in the evaluation of the Loestrin product line.
`As such, a total of seventeen names were analyzed to determine if the drug names could be confused with
`Lo Loestrin Fe and if the drug name confusion would likely result in a medication error.
`
`6
`
`(b) (4)
`
`

`

`Five names represent Loestrin products that are currently marketed (see Appendix F). The Loestrin
`product line will be discussed in detail in Section 4.
`Three names lacked convincing orthographic and/or phonetic similarity and were not evaluated further
`(see Appendix G).
`Failure mode and effects analysis (FMEA) was then applied to determine if the proposed name, Lo
`Loestrin Fe, could potentially be confused with any of the nine remaining names and lead to medication
`errors. This analysis determined that the name similarity between Lo Loestrin Fe and the identified
`names was unlikely to result in medication errors with any of the nine products identified for the reasons
`presented in Appendices H through J. This assessment is supported in part by the lack of medication
`errors with the approved Loestrin products and other drug products.
`
`4 DISCUSSION
`Neither DDMAC nor the Division of Reproductive and Urologic Products had concerns with the
`proposed name, Lo Loestrin Fe. DMEPA did not identify factors, other than names with potential
`similarity to Lo Loestrin Fe, that would render the name unacceptable.
`
`4.1 USE OF “LO” AND “FE” MODIFIERS
`As part of our FMEA we evaluated the potential for medication errors to occur due to misinterpretation of
`the modifiers “Lo” and “Fe”.
`
`4.1.1 Precedence
`We note that the proposed name includes the modifiers “Lo” and “Fe”, and that no data was provided to
`support that the modifiers would not inadvertently introduce a source of error. However, we also note
`that the “Fe” modifier is used consistently within the Loestrin product line, as well as for other approved
`oral contraceptives, to represent the ferrous fumarate component. In our review of the proposed name
` (see RCM #2009-651, dated July 8, 2009), DMEPA conducted a search of the FDA
`Adverse Event Reporting System (AERS) to identify potential problems with the nomenclature of the
`Loestrin product line. At that time we retrieved seven reports involving confusion between the strengths
`of the Loestrin Fe products,
` No
`cases of confusion between Loestrin Fe and the non-iron containing Loestrin products were identified,
`which helps to support the safety of the “Fe” modifier.
`Similarly, the “Lo” modifier is used for other approved oral contraceptive products to represent lower
`estrogen content or lower estrogen and progestin content. The Applicant’s intended meaning of the “Lo”
`modifier for the proposed product follows this established trend because we know how much estrogen Lo
`Loestrin Fe provides, which is lower on a daily and monthly basis than the other Loestrin products (see
`Appendix F).
`Therefore, although this Applicant has not provided data to support the use of the proposed modifiers,
`DMEPA believes that the post-marketing experience with the Loestrin product line and the consistent use
`of the proposed modifiers with other approved products adequately supports their use for the proposed
`product. Thus, in consideration of the total data available, DMEPA does not object to the use of the
`modifiers, “Lo” and “Fe”.
`
`4.1.2 Other Safety Concerns
`The CDER Expert Panel discussed the following concerns with the “Lo” modifier: “Lo” may be
`overlooked; what does “Lo” convey?; “Lo” can look like the number “10”; “Lo” may be interpreted as a
`stutter and omitted when transcribed from verbal orders; seems like a typographical error with double
`“Lo”.
`
`7
`
`(b) (4)
`
`(b) (4)
`
`

`

`Additionally, the Expert Panel indicated that either of the modifiers (“Lo” or “Fe”) could be omitted from
`prescriptions or medication orders. We note post-marketing evidence has shown that the omission of
`modifiers is a phenomenon that contributes to medication errors. However, post-marketing evidence has
`also shown that placement of the modifier as a prefix or infix, as opposed to a suffix, decreases the risk of
`such errors. Because there are five marketed Loestrin products, the omission of any of the modifiers on a
`prescription or medication order would require clarification from the prescribing healthcare practitioner
`before dispensing a product, thus preventing a dispensing error. Similarly, if the modifier ‘Lo’ was
`misinterpreted as the number ‘10’ on a prescription or medication order, a pharmacist would need to seek
`clarification of the order since ‘10’ is not a modifier utilized for the currently marketed Loestrin product
`line. This clarification would prevent a dispensing error.
`Finally, the Expert Panel identified several definitions for the medical abbreviation “Lo”: lateral oblique,
`linguo-occlusal, low lumber orthosis, lenticular opacity, leucine oxidation, and loss. However