NDA 21920/S-025
`
`
`
`
`
`
`
`
`
` 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) received April 26, 2019,
`
` and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
`
`
`
`
`
`
`
`
`
` Cosmetic Act (FDCA) for naproxen sodium capsule, 220 mg.
`
`
`
`
`
`
`
`
` This prior approval supplemental new drug application provides for the following two
`
`
`
`
`
` product line extensions:
` back and muscle pain relief
`
`
`
`
`-
`
` - menstrual pain relief
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 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 labeling, with the
`
`
`
`
`
`
`
`
`
`
`
`
` minor editorial revision listed below:
`
`
`
`
`
`
`
`
`
`
`
`
` Revise the proposed 100-count immediate container (stand-alone bottle) Drug Facts
`
`
` label (DFL) (i.e., labels with and without the “compare to” statement), and submit
`
`
`
`
`
`
`
`
`
`
`
` revised labels as final printed labeling (FPL):
`
`
`
`
`
`
`
`
`
`
`
`
`
` Revise the proposed warning according to 21 CFR 201.66(d)(6) from:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` to
`
`“Warnings
`
`
`Allergy alert: Naproxen sodium may cause …”
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4511736
`
`(b) (4)
`
`

`

`
`
`
`
`
` NDA 21920/S-025
`
` Page 2
`
`
`
` 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
`
`
`
`
`
`
`
`
`
`
` described in the table below, except for the revision listed above, and must be in the
`
`
`
`
`
`
`
`
`
`
`
`
`
` “Drug Facts” format (21 CFR 201.66), where applicable.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Date Submitted
`
`
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` Submitted Labeling for Approval
` 50-Count Outer Carton with “12 Hour Back & Muscle Pain Relief”
`
`
`
`
` Descriptor and “Compare To” Statement
`
`
`
` 50-Count Outer Carton with “12 Hour Back & Muscle Pain Relief”
`
`
`
`
` Descriptor
`
`
` 50-Count Immediate Container (bottle) with “12 Hour Back & Muscle
`
` Pain Relief” Descriptor
`
`
`
`
`
` 100-Count Immediate Container (stand-alone bottle) with “12 Hour
`
`
` Back & Muscle Pain Relief” Descriptor and “Compare To” Statement
`
`
`
`
`
` 100-Count Immediate Container (stand-alone bottle) with “12 Hour
`
`
`
`
`
` Back & Muscle Pain Relief” Descriptor
`
`
`
`
` 20-Count Outer Carton with “12 Hour Menstrual Pain Relief” Descriptor
`
`
`
`
` and “Compare To” Statement
`
`
`
` 40-Count Outer Carton with “12 Hour Menstrual Pain Relief” Descriptor
`
`
`
` and “Compare To” Statement
`
`
`
` 80-Count Outer Carton with “12 Hour Menstrual Pain Relief” Descriptor
`
`
`
` and “Compare To” Statement
`
`
`
`
`
`
`
`
`
` 20-Count Outer Carton with “12 Hour Menstrual Pain Relief” Descriptor October 9, 2019
`
`
`
`
`
`
`
`
`
`
` 40-Count Outer Carton with “12 Hour Menstrual Pain Relief” Descriptor October 9, 2019
`
`
`
` 80-Count Outer Carton with “12 Hour Menstrual Pain Relief” Descriptor October 9, 2019
`
`
`
`
`
`
`
`
`
` 20-Count Immediate Container (bottle) with “12 Hour Menstrual Pain
`
`
`
`
`
` Relief” Descriptor
`
` 40-Count Immediate Container (bottle) with “12 Hour Menstrual Pain
`
` Relief” Descriptor
`
` 80-Count Immediate Container (bottle) with “12 Hour Menstrual Pain
`
` Relief” Descriptor
`
`
`
`
`
`
`
`
`
`
`
`
` 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-025.” Approval of this submission by FDA is not
`
`
`
`
`
`
`
`
`
`
`
`
` required before the labeling is used.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` October 9, 2019
`
`
`
`
`
` 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.
`
`
`
`
`
`
`
` U.S. Food and Drug Administration
` Silver Spring, MD 20993
`
`
`
`
` www.fda.gov
`
`
`
`
`
`
`
`
`Reference ID: 4511736
`
`

`

`
`
`
`
`
`
`
`
`
`
`
` NDA 21920/S-025
`
` Page 3
`
`
`
` DRUG REGISTRATION AND LISTING
`
` 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.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 LT Sally Doan, Regulatory Project Manager,
` at 301-796-8025.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Sincerely,
`
`
` {See appended electronic signature page}
`
`
`
` Karen Murry Mahoney, MD, FACE
` Deputy Director
`
`
`
` Division of Nonprescription Drug Products
`
`
`
` Office of Drug Evaluation IV
`
`
`
`
` Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` ENCLOSURE(S):
`
`• Carton and Container Labeling
`
`
`
`
`
`
`
`
`
`
` 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: 4511736
`
`

`

`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
`10/26/2019 09:21:31 PM
`
`Reference ID: 4511736
`
`