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` NDA 21920/S-026
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` SUPPLEMENT APPROVAL
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`Bionpharma, Inc.
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`Attention: Usha Sankaran
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`Associate VP, Regulatory Affairs
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`600 Alexander Road, 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 10, 2019, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for naproxen sodium capsules, 220 mg.
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`This Changes Being Effected (CBE) supplemental new drug application provides for the
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`addition of “[bullet] taking aspirin for heart attack or stroke, because naproxen may
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`decrease this benefit of aspirin” under the Warnings subheading, “Ask a doctor or
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`pharmacist before use if you are”, in accordance with the Agency’s May 9, 2019, CBE
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`Supplement Request Letter.
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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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`delineated in the table below, and must be in the “Drug Facts” format (21 CFR 201.66),
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`where applicable.
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`Reference ID: 4530821
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` NDA 21920/S-026
` Page 2
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` Submitted Labeling for Approval
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` 20-count outer carton
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` 20-count outer carton with “compare to statement”
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` 30-count outer carton
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` 30-count outer carton with “compare to statement”
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`40-count outer carton
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` 40-count outer carton with “compare to statement”
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`50-count outer carton
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` 50-count outer carton with “compare to statement”
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` 80-count outer carton
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` 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”
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` 100-count outer carton
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` 100-count outer carton with “compare to statement”
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` 120-count outer carton
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` 120-count outer carton with “compare to statement”
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` 160-count outer carton
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` 160-count outer carton with “compare to statement”
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` 160-count (2 x 80-count) outer carton (promotional twin-pack)
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` 160-count (2 x 80-count) outer carton (promotional twin-pack)
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` with “compare to statement”
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`SUBMITTED LABELING FOR APPROVAL
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` 20-count immediate container
` 20-count immediate container with “compare to statement”
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` 30-count immediate container
` 30-count immediate container with “compare to statement”
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` 40-count immediate container
` 40-count immediate container with “compare to statement”
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` 50-count immediate container
` 50-count immediate container with “compare to statement”
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` 80-count immediate container
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` 80-count immediate container with “compare to statement”
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` 80-count immediate container (nonchild-resistant packaging)
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` 80-count immediate container (nonchild-resistant packaging) with
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` “compare to statement”
` 100-count immediate container
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` 100-count immediate container with “compare to statement”
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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: 4530821
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` Date Submitted
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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` September 09, 2019
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`Date Submitted
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` September 09, 2019
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` September 09, 2019
` October 31, 2019
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` October 31, 2019
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` NDA 21920/S-026
` Page 3
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` 120-count immediate container
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` 120-count immediate container with “compare to statement”
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` 160-count immediate container
` 160-count immediate container with “compare to statement”
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` 160-count stand-alone immediate container
`160-count stand-alone immediate container with “compare to
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` statement”
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` October 31, 2019
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` November 15, 2019
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` November 15, 2019
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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-026.” 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
`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
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`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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` 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: 4530821
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`NDA 21920/S-026
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`Page 4
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`If you have any questions, call CAPT Janice Adams-King, Safety Regulatory Project
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`Manager, at 301-796-3713.
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`Sincerely,
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`{See appended electronic signature page}
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`Valerie Pratt, MD
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`Deputy Director for Safety
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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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`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: 4530821
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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/
`------------------------------------------------------------
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`VALERIE S PRATT
`12/09/2019 01:06:42 PM
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`Reference ID: 4530821
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