CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICATION NUMBER:
`
`209089Orig1s000
`
`
` 209090Orig1s000
`
` Xyzal Allergy 24HR
`
`levocetirizine dihydrochloride
`
`Trade Name:
`
`Generic or Proper
`Name:
`
`Sponsor:
`
`
`
`
`Approval Date:
`
`
`Indication:
`
`
`Sanofi-aventis U.S. LLC
`
`January 26, 2017
`
`Temporarily relieves these symptoms due to hay fever or
`other upper respiratory allergies:
`
` runny nose
` sneezing
` itchy,watery eyes
` itching of the nose or throat
`
`

`

`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
` 209089Orig1s000
` 209090Orig1s000
`
`
`
`
`
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Clinical Review(s)
`Product Quality Review(s)
`Non-Clinical Review(s)
`Statistical Review(s)
`Clinical Microbiology / Virology Review(s)
`Clinical Pharmacology Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`
`X
`
`X
`X
`
`X
`X
`X
`X
`X
`
`X
`X
`
`X
`X
`
`

`

`
`
`APPLICATION NUMBER:
`
` 209089Orig1s000
` 209090Orig1s000
`
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPROVAL LETTER
`
`

`

`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`NDA 209089
`NDA 209090
`
`sanofi-aventis U.S. LLC
`Attention: Cynthia Psaras, PhD
`
` Director, Global Regulatory Affairs
`55 Corporate Drive
`Mail Stop 55D-225A
`Bridgewater, NJ 08807
`
`Dear Dr. Psaras:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`Please refer to your New Drug Applications (NDAs) dated and received March 31, 2016, and
`your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for the following NDAs:
`(cid:120) NDA 209089: Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets, 5 mg
`(cid:120) NDA 209090: Xyzal Allergy 24HR (levocetirizine dihydrochloride)
`oral solution, 2.5 mg per 5 mL (0.5 mg per mL).
`
`These NDAs for the use of Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets, 5 mg
`and Xyzal Allergy 24HR (levocetirizine dihydrochloride) oral solution, 2.5 mg per 5 mL (0.5 mg
`per mL) provide for the following indication:
`
`Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
`runny nose
`(cid:120)
`sneezing
`(cid:120)
`itchy, watery eyes
`(cid:120)
`itching of the nose or throat
`(cid:120)
`
`We have completed our review of these applications, as amended. They are approved, effective
`on the date of this letter, for use as recommended in the agreed-upon labeling text.
`
`LABELING
`
`Submit final printed labeling (FPL), as soon as they are available, but no more than 30 days after
`they are printed. The FPL for NDA 209089 must be identical to the 10-count carton (blister),
`10-count immediate container (blister), 35-count carton (bottle), 35-count immediate container
`(bottle), 45-count carton Bonus (bottle), 45-immediate container Bonus (bottle), 55-count carton
`(bottle), 55-count immediate container (bottle), 80-count carton (bottle), 80-count immediate
`container (bottle), and 110-count club pack (bottle) labeling submitted on January 9, 2017, and
`
`Reference ID: 4048999
`
`

`

`NDA 209089
`NDA 209090
`Page 2
`
`bottle seal label submitted on March 31, 2016, and must be in the "Drug Facts" format (21 CFR
`201.66), where applicable.
`
`The FPL for NDA 209090 must be identical to the 5 fluid ounce (fl. oz.) carton (bottle)
`Children's Tutti-Frutti Flavor, 5 fluid ounce (fl. oz.) immediate container (bottle) labeling and
`Oral Solution Dosing Cup labeling representation submitted on January 9, 2017 and bottle seal
`label submitted on March 31, 2016 and must be in the "Drug Facts" format (21 CFR 201.66),
`where applicable.
`
`The FPL should be submitted electronically according to the guidance for industry titled
`“Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical
`Product Applications and Related Submissions Using the eCTD Specifications (May 2015,
`Revision 3).” For administrative purposes, designate this submission “Final Printed Labeling
`for approved NDA 209089” or “Final Printed labeling for approved NDA 209090” as
`appropriate. Approval of these submissions by FDA are not required before the labeling is used.
`
`DRUG REGISTRATION AND LISTING
`
`All drug establishment registration and drug listing information is to be submitted to FDA
`electronically, via the FDA automated system for processing structured product labeling (SPL)
`files (eLIST). At the time that you submit your final printed labeling (FPL), the content of
`labeling (Drug Facts) should be submitted in SPL format as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Information on submitting SPL files using eLIST may be found in the guidance for industry
`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf. In addition, representative container or carton labeling, whichever includes
`Drug Facts, (where differences exist only in the quantity of contents statement) should be
`submitted as a JPG file.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`Because none of these criteria apply to your applications, you are exempt from this requirement.
`
`Reference ID: 4048999
`
`

`

`NDA 209089
`NDA 209090
`Page 3
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA.
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Sherry Stewart, Regulatory Project Manager, at (301) 796-9618.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Theresa Michele, MD
`Director
`Division of Nonprescription Drug Products
`Office of Drug Evaluation IV
`Center for Drug Evaluation and Research
`
`ENCLOSURES:
`Carton and Container Labeling
`
`Reference ID: 4048999
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`THERESA M MICHELE
`01/31/2017
`
`Reference ID: 4048999
`
`(
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