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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21920/S-023
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`Food and Drug Administration
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`Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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`Bionpharma Inc.
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`Attention: Usha Sankaran
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`Associate 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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`August 27, 2018, and your amendments, submitted under section 505(b) of the Federal Food,
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`Drug, and Cosmetic Act (FDCA) for naproxen sodium capsule, 220 mg.
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`This “Prior Approval” supplemental new drug application provides labeling for two versions of
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`160-count cartons, to accommodate different distributors. Each version will contain two 80­
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`count bottles.
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`We have completed our review of this application, as amended. It is approved, effective on the
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`date of this letter, for use as recommended in the agreed-upon labeling text.
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`LABELING
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`Submit final printed labeling, as soon as they are available, but no more than 30 days after they
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`are printed. The final printed labeling must be identical to the labeling below and must be in the
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`“Drug Facts” format (21 CFR 201.66), where applicable.
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` Submitted Labeling for Approval
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` Naproxen Sodium Capsules 160-ct carton (twin-pack (2 x 80-ct)) with
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` “compare to the active ingredient of ALEVE® Liquid Gels” statement
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`Naproxen Sodium Capsules 160-ct carton (twin-pack (2 x 80-ct)) without
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` “compare to the active ingredient of ALEVE® Liquid Gels” statement
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` Date Submitted
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` January 22, 2019
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` January 22, 2019
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`Reference ID: 4393224
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` NDA 21920/S-023
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` Page 2
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` The final printed labeling should be submitted electronically according to the guidance for
` industry titled Providing Regulatory Submissions in Electronic Format — Certain Human
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` Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
` (April 2017, Revision 4). For administrative purposes, designate this submission “Final Printed
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` Labeling for approved NDA 21920/S-023.” 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 are to be submitted to FDA
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`electronically, via the FDA automated system for processing structured product labeling (SPL)
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`files (eLIST). At the time that you submit your final printed labeling (FPL), the content of
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`labeling (Drug Facts) should be submitted in SPL format as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf. In addition, representative container or carton labeling, whichever includes
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`Drug Facts, (where differences exist only in the quantity of contents statement) should be
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`submitted as a JPG file.
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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 Tinya Sensie, Regulatory Project Manager at (240) 402-4230.
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`ENCLOSURE(S):
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`Carton and Container Labeling
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`Reference ID: 4393224
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`Sincerely,
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`{See appended electronic signature page}
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`Karen Murry Mahoney, MD, FACE
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`Deputy Director
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`Division of Nonprescription Drug Products
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`Office of Drug Evaluation IV
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`Center for Drug Evaluation and Research
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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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`KAREN M MAHONEY
`02/20/2019 05:05:43 PM
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`Reference ID: 4393224
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`(
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