`
`
` NDA 209090/S-2
`
`
`
`
` SUPPLEMENT APPROVAL
`
`
`
`
`Sanofi-Aventis U.S. LLC
`
`
`Attention: Christine Dellanno,
`
`
`Category Head - Allergy, Cough & Cold, US Regulatory Affairs CHC
`
`55 Corporate Drive
`
`Bridgewater, NJ 08807
`
`
`
`
`Dear Ms. Dellanno:
`
`
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received May
`
`
`
`
`12, 2020, your amendment, submitted under section 505(b) of the Federal Food, Drug,
`
`
`
`and Cosmetic Act (FDCA) for Children’s Xyzal Allergy 24 HR (levocetirizine
`
`dihydrochloride) oral solution, 2.5 mg per 5 mL (0.5 mg per mL).
`
`
`
`
`
`This “Prior Approval” supplemental new drug application provides for revised labeling to
`
`
`
`redesign the principal display panel and bottle label.
`
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`
`
`
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`
`labeling.
`
`
`LABELING
`
`
`
`
`
`Submit final printed labeling (FPL) as soon as they are available, but no more than 30
`
`
`days after they are printed. The FPL must be identical to the enclosed labeling,
`
`
`
`described in the table below, and must be in the “Drug Facts” format (21 CFR 201.66),
`
`where applicable.
`
`
` Submitted Labeling
`
`
`
` 5 fl. oz outer container
` 5 fl. oz bottle (immediate container)
`
`
`
`
`
`
` Date Submitted
`
` 10/16/2020
`
` 10/16/2020
`
`Reference ID: 4699590
`
`
`
`
`
`
`
`
` NDA 209090/S-2
` Page 2
`
`
`
`
` The FPL should be submitted electronically according to the guidance for industry
`
`
`
`
` Providing Regulatory Submissions in Electronic Format — Certain Human
` Pharmaceutical Product Applications and Related Submissions Using the eCTD
`
`
`Specifications.1 For administrative purposes, designate this submission “Final Printed
`
`
`
`
`Labeling for approved NDA 209090/S-2.” Approval of this submission by FDA is 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
`
`
`
` FDA.gov.2 Information on submitting SPL files using eLIST may be found in the
`
`
`
`
`guidance for industry SPL Standard for Content of Labeling Technical Qs and As. 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.
`
`
`REPORTING REQUIREMENTS
`
`
`
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
` 1 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
` 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`
`
`
`
`Reference ID: 4699590
`
`
`
`NDA 209090/S-2
`
`
`Page 3
`
`
`
`If you have any questions, call Sherry Stewart, PharmD, Senior Regulatory Project
`
`
`
`Manager, at (301) 796-9618.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Nushin Todd, MD, PhD
`
`
`
`Deputy Director (Acting)
`
`
`Division of Nonprescription Drugs I
`
`Office of Nonprescription Drugs
`
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURES:
`
`• Carton and Container Labeling
`
`
`
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4699590
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`NUSHIN F TODD
`11/10/2020 08:27:55 AM
`
`Reference ID: 4699590
`
`