CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`209089Orig1s000
` 209090Orig1s000
`
`
`
`PROPRIETARY NAME REVIEW(S)
`
`
`

`

`PROPRIETARY NAME MEMORANDUM
`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:
`Application Type and Number:
`Product Name and Strength:
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`May 26, 2016
`NDA 209089
`Xyzal Allergy 24HR (levocetirizine dihydrochloride)
`Tablets, 5 mg
`Single-Ingredient Product
`OTC
`Sanofi US Services Inc.
`2016-3246951
`Grace P. Jones, PharmD, BCPS
`Chi-Ming (Alice) Tu, PharmD
`
`Reference ID: 3937462
`
`

`

`INTRODUCTION
`1
`This memorandum is to reassess the proposed proprietary name, Xyzal Allergy 24HR, which was
`found conditionally acceptable under IND 126506 and IND 126507 on March 14, 2016.1 We
`note that all product characteristics remain the same.
`
`2 METHODS AND DISCUSSION
`The Applicant is proposing a partial Rx-to-OTC switch providing for the OTC use for the
`treatment of symptoms due to seasonal and perennial allergic rhinitis in children ages 2 years
`and older and adults up to 65 years of age. The Applicant currently is not seeking OTC use for
`the hives indication. For re-assessment of the proposed proprietary name, DMEPA considered
`any lessons learned from recent post-marketing experience, which may have altered our
`previous conclusion regarding the acceptability of the proposed proprietary name, and
`conducted a gap FDA Adverse Event Reporting System (FAERS) database search on May 17,
`2016 to identify any new medication error reports for product name confusion related to the
`root name Xyzal, which retrieved no cases. Additionally, DMEPA searched the USAN stem list
`to determine if the name contains any USAN stems as of the last USAN updates. The May 9,
`2016 search of USAN stems did not find any USAN stems in the proposed proprietary name.
`
`2.1 MISBRANDING ASSESSMENT
`The Division of Nonprescription Drug Products (DNDP) determined that the proposed name
`would not misbrand the proposed product. DMEPA concurred with DNDP’s assessment of the
`proposed name.
`
`CONCLUSIONS
`3
`Our re-assessment did not identify any concerns that represent a potential source of drug name
`confusion. Therefore, we maintain that the proposed proprietary name is acceptable.
`
`If you have any questions or need clarifications, please contact Abiola Olagundoye-Alawode,
`OSE project manager, at 301-796-3982.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Xyzal Allergy 24HR, and
`have concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your March 31, 2016 submission are
`altered prior to approval of the marketing application, the name must be resubmitted for
`review.
`
`1 Jones, G. Proprietary Name Review for Xyzal Allergy 24HR (IND 126506 and IND 126507). 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); 2016 MAR 14. Panorama No. 2015-1541618, 2015-
`1541620.
`
`Reference ID: 3937462
`
`

`

`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. Description of FAERS
`The FDA Adverse Event Reporting System (FAERS) is a database that contains information
`on adverse event and medication error reports submitted to FDA. The database is designed
`to support the FDA's postmarket safety surveillance program for drug and therapeutic
`biologic products. The informatic structure of the FAERS database adheres to the
`international safety reporting guidance issued by the International Conference on
`Harmonisation. FDA’s Office of Surveillance and Epidemiology codes adverse events and
`medication errors to terms in the Medical Dictionary for Regulatory Activities (MedDRA)
`terminology. Product names are coded using the FAERS Product Dictionary. More
`information about FAERS can be found at:
`http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/Adver
`seDrugEffects/default.htm.
`
`Reference ID: 3937462
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`GRACE JONES
`05/26/2016
`
`CHI-MING TU
`05/26/2016
`
`Reference ID: 3937462
`
`

`

`PROPRIETARY NAME MEMORANDUM
`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:
`Application Type and Number:
`Product Name and Strength:
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`May 26, 2016
`NDA 209090
`Children’s Xyzal Allergy 24HR (levocetirizine
`dihydrochloride) Oral Solution, 2.5 mg/5 mL
`Single-Ingredient Product
`OTC
`Sanofi US Services Inc.
`2016-3246956
`Grace P. Jones, PharmD, BCPS
`Chi-Ming (Alice) Tu, PharmD
`
`Reference ID: 3937472
`
`

`

`INTRODUCTION
`1
`This memorandum evaluates the proposed proprietary name, Children’s Xyzal Allergy 24HR,
`from a safety and misbranding perspective.
`We previously reviewed the proposed proprietary name, Xyzal Allergy 24HR, for levocetirizine
`dihydrochloride tablets, 5 mg, and oral solution, 2.5 mg/5 mL, which was found conditionally
`acceptable under IND 126506 and IND 126507 on March 14, 2016.1 Upon NDA 209090
`submission, Sanofi clarified that the oral solution dosage form will only be marketed as a
`“Children’s” OTC product. The proposed container labels and carton labeling utilized
`“Children’s Xyzal Allergy 24HR” as the proprietary name. Based on DMEPA’s feedback, Sanofi
`submitted the proposed proprietary name, Children’s Xyzal Allergy 24HR, for levocetirizine
`dihydrochloride oral solution, 2.5 mg/5 mL.
`
`2 METHODS AND DISCUSSION
`The Applicant is proposing a partial Rx-to-OTC switch providing for the OTC use for the
`treatment of symptoms due to seasonal and perennial allergic rhinitis in children ages 2 years
`and older and adults up to 65 years of age. The Applicant currently is not seeking OTC use for
`the hives indication. For assessment of the proposed proprietary name, DMEPA considered any
`lessons learned from recent post-marketing experience, which may have altered our previous
`conclusion regarding the acceptability of the proposed proprietary name, and conducted a gap
`FDA Adverse Event Reporting System (FAERS) database search on May 17, 2016 to identify any
`new medication error reports for product name confusion related to the root name Xyzal,
`which retrieved no cases. Additionally, DMEPA searched the USAN stem list to determine if the
`name contains any USAN stems as of the last USAN updates. The May 9, 2016 search of USAN
`stems did not find any USAN stems in the proposed proprietary name.
`
`Additionally, the Applicant intends to market Children’s Xyzal Allergy 24HR (levocetirizine
`dihydrochloride oral solution) for the same OTC use as the Xyzal Allergy 24HR, for the
`temporary relief of symptoms due to hay fever or other respiratory allergies (runny nose,
`sneezing, itchy, watery eyes, and itching of the nose or throat) in adults and children ages 2
`years and older, as pediatric SKU. The Drug Facts Label (DFL) is the same for the proposed
`Children’s Xyzal Allergy 24HR and the proposed Xyzal Allergy 24Hr, except for the directions for
`the Children’s Xyzal Allergy 24HR which contains directions for use in children 2 years of age
`and older. We note this naming convention of adding “Children’s” to OTC products for a
`pediatric SKU is common among existing OTC products marketed under an application. The DFL
`of these OTC products are also the same with directions for both adults and children (i.e. Zyrtec
`Allergy and Children’s Zyrtec Allergy; and Claritin and Children’s Claritin). We are unaware of
`post-marketing medication errors associated with this naming convention.
`
`1 Jones, G. Proprietary Name Review for Xyzal Allergy 24HR (IND 126506 and IND 126507). 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); 2016 MAR 14. Panorama No. 2015-1541618, 2015-
`1541620.
`
`Reference ID: 3937472
`
`

`

`CONCLUSIONS
`3
`Our assessment did not identify any concerns that represent a potential source of drug name
`confusion. Therefore, we find the proposed proprietary name Children’s Xyzal Allergy 24HR,
`acceptable for this product.
`
`If you have any questions or need clarifications, please contact Abiola Olagundoye-Alawode,
`OSE project manager, at 301-796-3982.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Children’s Xyzal Allergy
`24HR, and have concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your April 27, 2016 submission are
`altered prior to approval of the marketing application, the name must be resubmitted for
`review.
`
`Reference ID: 3937472
`
`

`

`4
`
`REFERENCES
`
`1. USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical-
`science/united-states-adopted-names-council/naming-gidelines/approved-stems.page)
`USAN Stems List contains all the recognized USAN stems.
`
`2. Description of FAERS
`The FDA Adverse Event Reporting System (FAERS) is a database that contains information
`on adverse event and medication error reports submitted to FDA. The database is designed
`to support the FDA's postmarket safety surveillance program for drug and therapeutic
`biologic products. The informatic structure of the FAERS database adheres to the
`international safety reporting guidance issued by the International Conference on
`Harmonisation. FDA’s Office of Surveillance and Epidemiology codes adverse events and
`medication errors to terms in the Medical Dictionary for Regulatory Activities (MedDRA)
`terminology. Product names are coded using the FAERS Product Dictionary. More
`information about FAERS can be found at:
`http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/Adver
`seDrugEffects/default.htm.
`
`Reference ID: 3937472
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`GRACE JONES
`05/26/2016
`
`CHI-MING TU
`05/26/2016
`
`Reference ID: 3937472
`
`(
`
`
`
`