`NDA 21920/S-033
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` SUPPLEMENT APPROVAL
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`Bionpharma Inc.
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`Attention: Usha Sankaran
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`Vice President, Regulatory Affairs
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`600 Alexander Road
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`Suite 2-4B
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`Princeton, NJ 08540
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`Dear Ms. Sankaran:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`June 24, 2020, and your amendment, submitted pursuant to section 505(b)(2) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for naproxen sodium capsule, 220 mg.
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`This Prior Approval supplemental new drug application provides for labeling with an
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`alternate design in the Principal Display Panel (PDP).
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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, and
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`must be in the “Drug Facts” format (21 CFR 201.66), where applicable.
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`Reference ID: 4716208
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` NDA 21920/S-033
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` Page 2
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` Submitted Labeling for Approval
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` 20-count outer carton
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`50-count outer carton
` 80-count outer carton
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` 80-count outer carton (nonchild-resistant packaging)
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` 120-count outer carton (design 1)
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` 120-count outer carton (design 2)
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` 20-count immediate container
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` 50-count immediate container
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` 80-count immediate container
` 80-count immediate container (nonchild-resistant packaging)
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` 120-count immediate container
` 160-count stand-alone immediate container
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` Date Submitted
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` June 24, 2020
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` October 28, 2020
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` June 24, 2020
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` June 24, 2020
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` June 24, 2020
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` June 24, 2020
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` October 28, 2020
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` June 24, 2020
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` June 24, 2020
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` June 24, 2020
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` June 24, 2020
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` June 24, 2020
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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 21920/S-033.” 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,
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`(where differences exist only in the quantity of contents statement) should be submitted
`as a JPG file.
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`PROPRIETARY NAME
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`If you intend to have a proprietary name for this product, the name and its use in the
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`labels must conform to the specifications under 21 CFR 201.10 and 201.15. We
`recommend that you submit a request for a proposed proprietary name review. (See the
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`guidance for industry Contents of a Complete Submission for the Evaluation of
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` 1 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` 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: 4716208
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` NDA 21920/S-033
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` Page 3
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`Proprietary Names and PDUFA Reauthorization Performance Goals and Procedures –
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`Fiscal Years 2018 Through 2022.)
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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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`If you have any questions, call LCDR Sally Doan, Regulatory Project Manager,
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`at 301-796-8025.
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`Sincerely,
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`{See appended electronic signature page}
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`Nushin Todd, MD, PhD
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`Acting Deputy 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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`ENCLOSURE(S):
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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: 4716208
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`Signature Page 1 of 1
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`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.
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`/s/
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`NUSHIN F TODD
`12/12/2020 12:18:39 PM
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`Reference ID: 4716208
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