`
` NDA 21920/S-027
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`
`
`
` SUPPLEMENT APPROVAL
`
`
`
`
`
`
`
`
` Biopharma Inc.
`
` Attention: Usha Sankaran
`
` Associate Vice President, Regulatory Affairs
`
` 600 Alexander Road
`
` Suite 2-4B
` Princeton, NJ 08540
`
`
` Dear Ms. Sankaran:
`
` Please refer to your supplemental new drug application (sNDA) dated and received
`
`
`
`
`August 27, 2019, submitted pursuant to section 505(b)(2) of the Federal Food, Drug,
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`
`
` and Cosmetic Act (FDCA) for naproxen sodium capsule, 220 mg.
`
` This Prior Approval supplemental new drug application provides for packaging and
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`
`
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` labeling for naproxen sodium capsule, 220 mg.
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` APPROVAL & LABELING
`
` We have completed our review of this application. It is approved, effective on the date of
`
`this letter, for use as recommended in the enclosed agreed-upon labeling.
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` 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, and
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`must be in the “Drug Facts” format (21 CFR 201.66), where applicable.
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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.1 For administrative purposes, designate this submission “Final Printed
`
` Labeling for approved NDA 21920/S-027.” Approval of this submission by FDA is not
`
`
` required before the labeling is used.
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`
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`
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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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`
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`Reference ID: 4567251
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`
` NDA 21920/S-027
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` Page 2
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` Dates Submitted
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` August 27, 2019
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` August 27, 2019
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`
`
` August 27, 2019
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`
`
` Submitted Labeling for Approval
`
` Naproxen sodium capsule 80-ct immediate container (bottle)
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` Naproxen sodium capsule 80-ct outer carton
`Naproxen sodium capsule 180-ct immediate container (stand-
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` alone bottle)
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` DRUG REGISTRATION AND LISTING
`
` 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
`(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
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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.
`
` 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 LT Sally Doan, Regulatory Project Manager, at (301)
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` 796-8025.
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`
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`
`
` Sincerely,
`
` {See appended electronic signature page}
`
` Karen Murry Mahoney, MD, FACE
`
`
` Acting Deputy Director, Office of Nonprescription Drugs
`
` Acting Deputy Director, Division of Nonprescription Drugs I
`
`
` Center for Drug Evaluation and Research
`
`
` ENCLOSURE(S):
`
`• Carton and Container Labeling
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`
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`
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`
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` 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
` U.S. Food and Drug Administration
`
` Silver Spring, MD 20993
`
` www.fda.gov
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`
`
`
`
`Reference ID: 4567251
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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/
`------------------------------------------------------------
`
`KAREN M MAHONEY
`02/27/2020 06:13:32 PM
`
`Reference ID: 4567251
`
`(
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