,,-,,.
`( ~ rffll U.S. FOOD & DRUG
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`ADMINISTRATION
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` NDA 209090/S-003
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` SUPPLEMENT APPROVAL
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`Chattem Inc. d/b/a Sanofi Consumer Healthcare
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`Attention: Monika A. Socha
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`Regulatory Lead – Allergy
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`CHC US Scientific Affairs
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`55 Corporate Drive
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`Bridgewater, NJ 08807
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`Dear Ms. Socha:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`October 25, 2021, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Children’s Xyzal Allergy 24HR
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`(levocetirizine dihydrochloride) oral solution, 2.5 mg per 5 mL (0.5 mg per mL).
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`We acknowledge receipt of your amendment dated March 15, 2022, which constituted a
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`resubmission after withdrawal of the sNDA.
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`This “Prior Approval” supplemental new drug application provides for the addition of a
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`new grape flavor variant of Children’s Xyzal Allergy 24HR, to be marketed in addition to
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`the currently approved tutti frutti flavor.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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`LABELING
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`Submit final printed labeling (FPL), as soon as they are available, but no more than 30
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`days after they are printed. The FPL must be identical to the enclosed labeling,
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`described in the table below and must be in the “Drug Facts” format (21 CFR 201.66),
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`where applicable. We remind you to remove the “NEW FLAVOR!” flag from the labeling
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`six months after the marketing start date.
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`Submitted Draft Labeling
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` grape flavor 5 fl. oz outer container
` grape flavor 5 fl. oz bottle label (immediate container)
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` Date submitted
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` 6/21/22
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` 6/21/22
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`Reference ID: 5011192
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` NDA 209090/S-003
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` Page 2
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` The FPL should be submitted electronically according to the guidance for industry
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` Providing Regulatory Submissions in Electronic Format — Certain Human
` Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications.1 For administrative purposes, designate this submission “Final Printed
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`Labeling for approved NDA 209090/S-003. Approval of this submission by FDA is not
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`required before the labeling is used.
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`DRUG REGISTRATION AND LISTING
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`All drug establishment registration and drug listing information is to be submitted to FDA
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`electronically, via the FDA automated system for processing structured product labeling
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`(SPL) files (eLIST). At the time that you submit your final printed labeling (FPL), the
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`content of labeling (Drug Facts) should be submitted in SPL format as described at
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`FDA.gov.2 Information on submitting SPL files using eLIST may be found in the
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`guidance for industry SPL Standard for Content of Labeling Technical Qs and As. In
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`addition, representative container or carton labeling, whichever includes Drug Facts,
`(where differences exist only in the quantity of contents statement) should be submitted
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`as a JPG file.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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` 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.
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` 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5011192
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`NDA 209090/S-003
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`Page 3
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`If you have any questions, call Phong Pham, PharmD, MBA, Regulatory Project
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`Manager, at (301) 837-7656.
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`Sincerely,
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`{See appended electronic signature page}
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`
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`Nushin Todd, MD, PhD
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`Director
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`Division of Nonprescription Drugs I
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`Office of Nonprescription Drugs
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Carton and Container Labeling
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5011192
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`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/
`------------------------------------------------------------
`
`SHERRY A STEWART
`07/13/2022 09:22:56 AM
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`NUSHIN F TODD
`07/13/2022 09:32:05 AM
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`-
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`Reference ID: 5011192
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`(
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