`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`NDA 021920/S-018
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`Bonus pack labeling statements to indicate the number of free capsules
`
`Instant redeemable coupons (IRCs)
`
`Banner Pharmacaps Inc.
`
`Attention: Vandana Garikipati, MS, RAC
`
`Manager, Regulatory Affairs
`4125 Premier Drive
`High Point, NC 27265
`
`
`Dear Ms. Garikipati:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated October 1, 2012,
`received October 2, 2012, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for naproxen sodium capsules, 220 mg.
`
`We acknowledge receipt of your amendment dated March 15, 2013.
`
`This “Prior Approval” supplemental new drug application proposes the following modifications:
`
`1.
`
`2.
`
`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 agreed-upon labeling text.
`
`LABELING
`
`
`Submit final printed labeling, as soon as they are available, but no more than 30 days after they
`are printed. The final printed labeling (FPL) must be identical to the carton and immediate
`container (bottle) labels submitted on March 15, 2013:
`
`
`1. Bonus Statement: X Free Liquid Gels with this Purchase
`
` 20-count bottle and carton with IRC (representative of Perrigo’s 30-count and Aleve®
`Liquid Gels 26-count)
`
` 40-count bottle and carton with IRC (representative of Perrigo’s 50- and 100-count, and
`Aleve® Liquid Gels 52-, 96-, and 104-count)
`
` 80-count non-child resistant bottle and carton with IRC (representative of Aleve® Liquid
`Gels non-child resistant 96- and 104-count)
`
`
`2. Bonus Statement: Bonus Size X + Y Free
`
`Reference ID: 3285755
`
`

`

`NDA 021920/S-018
`Page 2
`
`
`
`
` 20-count bottle and carton (representative of Perrigo’s 30-count)
`
` 40-count bottle and carton (representative of Perrigo’s 50- and 100-count)
`
`
`3. Bonus Statement: X + Y = Z Liquid Gels
`
` 20-count bottle and carton (representative of Perrigo’s 30-count)
`
` 40-count bottle and carton (representative of Perrigo’s 50- and 100-count)
`
`
`4. Instant Redeemable Coupon (IRC) Label
`
` 160-count bottle (representative of Aleve® Liquid Gels 160-count)
`
`The FPL must be in the “Drug Facts” format (21 CFR 201.66), where applicable and should
`include Banner labels for all sizes covered in this supplement plus the Instant Redeemable
`Coupon that will be used.
`
`The final printed labeling should be submitted electronically according to the guidance for
`industry titled “Providing Regulatory Submissions in Electronic Format – Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
`(June 2008).” Alternatively, you may submit 12 paper copies, with 6 of the copies individually
`mounted on heavy-weight paper or similar material. For administrative purposes, designate this
`submission “Final Printed Labeling for approved NDA 021920/S-018.” 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 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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Information on submitting SPL files using eLIST may be found in the guidance for industry
`
` titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf. 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).
`
`
`Reference ID: 3285755
`
`

`

`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`Joel Schiffenbauer, M.D.
`Deputy Director
`Division of Nonprescription Clinical Evaluation
`Office of Drug Evaluation IV
`Center for Drug Evaluation and Research
`
`NDA 021920/S-018
`Page 3
`
`
`If you have any questions, call Jade Pham, Regulatory Project Manager, at (301) 796-7031.
`
`
`
`ENCLOSURE(S):
`Carton and Container Labeling
`
`
`
`Reference ID: 3285755
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JOEL SCHIFFENBAUER
`04/01/2013
`
`Reference ID: 3285755
`
`