`
` NDA 21920/S-036
`
`
`
`
`
`
` SUPPLEMENT APPROVAL
`
`
`
`Bionpharma 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
`
`
`
`
`
`June 23, 2021, and your amendment, submitted pursuant to 505(b)(2) of the Federal
`
`
`
`Food, Drug, and Cosmetic Act (FDCA) for naproxen sodium capsules, 220 mg.
`
`
`
`
`
`This “Changes Being Effected” supplemental new drug application provides for an
`
`
`
`
`update under the “If pregnant or breast-feeding” warning in the Drug Facts labeling in
`
`response to the Agency’s CBE Supplement Request letter dated April 28, 2021.
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`
`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 labeling listed in the table
`
`
`
` below and must be in the “Drug Facts” format (21 CFR 201.66), where applicable.
`
`
`
`
`
`
` Submitted Labeling
`
`
`
`
`
`
`
`
`
` 20-Count outer carton
`
` 20-Count outer carton with “compare to” statement
`
` 20-Count outer carton-vertical orientation
`
` 30-Count outer carton
` 30-Count outer carton with “compare to” statement
`
` 40-Count outer carton
` 40-Count outer carton with “compare to” statement
`
`50-Count outer carton
` 50-Count outer carton with “compare to” statement
`
`
` 50-Count outer carton-vertical orientation
` 80-Count outer carton
`
`
`
`
`Reference ID: 4903813
`
`Dates
` Submitted
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`

`

`
`
`
` NDA 21920/S-036
`
` Page 2
`
`
`
`
`
`
`
`
`
`
`
`
`
` 80-Count outer carton with “compare to” statement
`
` 80-Count outer carton (nonchild resistant packaging)
`
` 80-Count outer carton (nonchild resistant packaging) with
`
` “compare to” statement
` 80-Count outer carton-vertical orientation
`
`80-Count outer carton (nonchild resistant packaging)-vertical
`
` orientation
`
`
` 100-Count outer carton
` 100-Count outer carton with “compare to” statement
`
`
`
` 120-Count outer carton
` 120-Count outer carton with “compare to” statement
`
`
`
` 120-Count outer carton-vertical orientation
`
`
` 120-Count outer carton-vertical orientation 2
`
` 160-Count (2x80-count) twin pack outer carton
`
`
` 160-Count (2x80-count) twin pack outer carton with “compare to”
`
` statement
`
`
` 160-Count outer carton
`
` 160-Count outer carton with “compare to” statement
` 160-Count immediate container
`
`
` 160-Count immediate container with “compare to” statement
`
`
` 160-Count immediate container-vertical orientation
`
` 180-Count immediate container
`
` 180-Count immediate container with “compare to” statement
`
`
` 300-Count immediate container (nonchild resistant packaging) with
`
` “compare to” statement
` 20-Count outer carton for menstrual pain line extension
`
`
` 20-Count outer carton with “compare to” statement for menstrual
`
` pain line extension
` 40-Count outer carton for menstrual pain line extension
`
`
` 40-Count outer carton with “compare to” statement for menstrual
`
` pain line extension
` 80-Count outer carton for menstrual pain line extension
`
`
` 80-Count outer carton with “compare to” statement for menstrual
`
` pain line extension
` 50-Count outer carton for back & muscle pain line extension
`
`
`
`
`
` 50-Count outer carton with “compare to statement” for back &
`
` muscle pain line extension
` 100-Count immediate container for back & muscle pain line
`
` extension
` 100-Count immediate container with “compare to statement” for
`
`
` back & muscle pain line extension
` 80-Count carton for “a+health” product line
`
` 120-Count immediate container (stand-alone bottle) for “a+health”
`
` product line
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
` June 23, 2021
`
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`
` June 23, 2021
`
`
`
`
`
` June 23, 2021
`
`
`
`
`
` June 23, 2021
`
`
` June 23, 2021
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4903813
`
`

`

`
`
`
` NDA 21920/S-036
`
` Page 3
`
`
`
`
`
` June 23, 2021
`
`
`
`
`
` June 23, 2021
`
`
` October 01,
`
` 2021
`
`
`
`
`
` 180-Count immediate container (stand-alone bottle) for “a+health”
`
` product line
` 80-Count carton for “Be Health” product line
`
` 180-Count immediate container (stand-alone bottle) for “Be Health”
`
` product line
`
`
`
`
` 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-036.” Approval of this submission by FDA is not
`
`
`
`
`
`required before the labeling is used.
`
`
`DRUG REGISTRATION AND LISTING
`All drug establishment registration and drug listing information are 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.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
`
`addition, representative container or carton labeling, whichever includes Drug Facts,
`
`
`(where differences exist only in the quantity of contents statement) should be submitted
`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 Helen Lee, PharmD, Safety Regulatory Project Manager,
`
`at 301-796-6848.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 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.
`
`
`
`
` 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`
`
`
`
`Reference ID: 4903813
`
`

`

`NDA 21920/S-036
`
`
`Page 4
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Valerie Pratt, MD
`
`Deputy Director for Safety
`
`Division of Nonprescription Drugs I
`
`Office of Nonprescription Drugs
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`ENCLOSURE(S):
`
`• Carton and Container Labeling
`
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4903813
`
`(
`
`
`
`

`

`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/
`------------------------------------------------------------
`
`VALERIE S PRATT
`12/13/2021 03:53:13 PM
`
`Reference ID: 4903813
`
`(
`
`
`
`