NDA 21920/S-028
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` SUPPLEMENT APPROVAL
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`Bionpharma Inc.
`Attention: Usha Sankaran
` Associate Vice President, Regulatory Affairs
`600 Alexander Road
`Suite 2-4B
`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
`October 4, 2019, and your amendments, submitted pursuant to section 505(b)(2) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for naproxen sodium capsule, 220 mg.
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`This Changes Being Effected supplemental new drug application proposes labeling with
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`“[bullet] protect from light” under Other information in the Drug Facts Labeling (DFL).
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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, with minor editorial revisions listed below.
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`Capitalize “avoid” and add a period after “(68-77°F)” in the statement “[bullet] store at
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`20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)”. Then,
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`change the proposed statement “[bullet] Protect from light.” to “[bullet] protect from light”
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`by removing the period and changing “Protect” to “protect”.
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`Current:
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`“[bullet] store at 20-25°C (68-77°F) avoid high humidity and
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`excessive heat above 40°C (104°F). [bullet] Protect from light.”
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`Corrected:
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`“[bullet] store at 20-25°C (68-77°F). Avoid high humidity and
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`excessive heat above 40°C (104°F). [bullet] protect from light”
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`LABELING
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`Submit final printed labeling (FPL), with the revisions listed above, as soon as they are
`available, but no more than 30 days after they are printed. The FPL must be identical to
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`Reference ID: 4601010
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`NDA 21920/S-028
`Page 2
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`the enclosed labeling and must be in the “Drug Facts” format (21 CFR 201.66), where
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`applicable.
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`Submitted Labeling for Approval
`20-count outer carton
` 20-count outer carton with “compare to statement”
`30-count outer carton
` 30-count outer carton with “compare to statement”
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` 40-count outer carton
` 40-count outer carton with “compare to statement”
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` 50-count outer carton
` 50-count outer carton with “compare to statement”
`80-count outer carton
` 80-count outer carton with “compare to statement”
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` 80-count outer carton (nonchild resistant packaging)
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`80-count outer carton (nonchild resistant packaging) with
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`“compare to statement”
`100-count outer carton
` 100-count outer carton with “compare to statement”
`120-count outer carton
` 120-count outer carton with “compare to statement”
`160-count outer carton
` 160-count outer carton with “compare to statement”
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`160-count (2 x 80-count) outer carton (promotional twin-pack)
`160-count (2 x 80-count) outer carton (promotional twin-pack)
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`with “compare to statement”
` 160-count immediate container (stand-alone bottle)
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`160-count immediate container (stand-alone bottle) with
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` “compare to statement”
` 80-count carton for “a+health” product line
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`120-count immediate container (stand-alone bottle) for “a+health”
`product line
`180-count immediate container (stand-alone bottle) for “a+health”
`product line
` 20-count outer carton for menstrual pain line extension
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`20-count outer carton with “compare to statement” for menstrual
`pain line extension
` 40-count outer carton for menstrual pain line extension
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`40-count outer carton with “compare to statement” for menstrual
`pain line extension
` 80-count outer carton for menstrual pain line extension
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`80-count outer carton with “compare to statement” for menstrual
`pain line extension
` 50-count outer carton for back & muscle pain line extension
`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Date Submitted
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
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`February 10, 2020
`February 10, 2020
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`February 10, 2020
`February 10, 2020
`February 10, 2020
`February 10, 2020
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`Reference ID: 4601010
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`

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` February 10, 2020
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`February 10, 2020
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`February 10, 2020
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`NDA 21920/S-028
`Page 3
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`50-count outer carton with “compare to statement” for back &
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` muscle pain line extension
`100-count immediate container (stand-alone bottle) for back &
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`muscle pain line extension
`100-count immediate container (stand-alone bottle) with
`“compare to statement” for back & muscle pain line extension
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`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.2 For administrative purposes, designate this submission “Final Printed
`Labeling for approved NDA 21920/S-028.” 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
`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.3 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
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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
`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
`guidance for industry Contents of a Complete Submission for the Evaluation of
`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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`2 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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` 3 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
`www.fda.gov
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`Reference ID: 4601010
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`NDA 21920/S-028
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`Page 4
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`If you have any questions, call LT Sally Doan, Regulatory Project Manager, at 301-796-
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`8025.
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`Sincerely,
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`{See appended electronic signature page}
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`
` Nushin Todd, MD, PhD
`
`Acting Deputy Director
`Division of Nonprescription Drugs I
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`x Carton and Container Labeling
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4601010
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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
`04/30/2020 03:05:23 PM
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`Reference ID: 4601010
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