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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021920/S-017
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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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`Banner Pharmacaps Inc.
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`Attention: Vandana Garikipati, MS, RAC
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`Manager, Regulatory Affairs
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`4125 Premier Drive
`High Point, NC 27265
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`Dear Ms. Garikipati:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 15, 2011,
`received December 16, 2011, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for naproxen sodium capsule, 220 mg.
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`We acknowledge receipt of your amendment dated June 8, 2012.
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`We also acknowledge that the December 15, 2011, submission references the November 17,
`2011, action letter to sNDA 021920, supplement 16.
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`This “Prior Approval” supplemental new drug application proposes the following labeling
`updates for naproxen sodium capsules, 220 mg, to better align with distributor labeling by Bayer
`Healthcare and Perrigo Pharmaceuticals:
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`1. Inclusion of the statement “Strength to Last 12 Hours” on the bottom left of the principal
`display panel (PDP)
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`2. Inclusion of the statement “Compare to the Active Ingredient of Aleve® Liquid Gels”
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`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.
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`We acknowledge that you do not market your product. However, we remind you that the
`distributors of your product must include an identifying characteristic (e.g., a pattern, name,
`registered trademark, logo, or picture) in the tamper evident statement and also as part of the
`tamper-evident feature in accordance with 21 CFR 211.132(b)(1).
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`Reference ID: 3144803
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`NDA 021920/S-017
`Page 2
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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
` are printed. The final printed labeling (FPL) must be identical to the enclosed labeling submitted
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`December 15, 2011, and must be in the “Drug Facts” format (21 CFR 201.66), where applicable:
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`Modified Label Format
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` 20-count immediate container (bottle) label
`o Representative of Perrigo’s 20-, and 30-count, and Bayer’s Aleve® Liquid Gels
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`20-count immediate container (bottle) label
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` 20-count carton label
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`o Representative of Aleve® Liquid Gels 20-count carton label
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` 40-count immediate container (bottle) label
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`o Representative of Perrigo’s 40-, 50-, 80-, 100-, and 160-count, and Aleve® Liquid
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`Gels 40-count immediate container (bottle) label
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`Standard Label Format
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` 40-count carton label
`o Representative of Perrigo’s 20-, 30-, 40-, 50-, 80-, 100-, and 160-count, and
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`Aleve® Liquid Gels 40-count carton label
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` 160-count immediate container (bottle) label
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`o Representative of Aleve® Liquid Gels 160-count carton label
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`Non-Child Resistant Format
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` 80-count non-child resistant immediate container (bottle) and carton label
`o Representative of Aleve® Liquid Gels 80-count immediate container (bottle) and
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`carton label
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`FPL must be submitted for all representative count sizes. Representative labeling will not be
`acceptable in the FPL submission.
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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 – 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-017.” Approval of this
`submission by FDA is not required before the labeling is used.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`Reference ID: 3144803
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`

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`NDA 021920/S-017
`Page 3
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`If you have any questions, call LT James Lee, Regulatory Project Manager, at (301) 796-5283.
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`Sincerely,
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`{See appended electronic signature page}
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`Joel Schiffenbauer, MD
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`Deputy Director
`Division of Nonprescription Clinical Evaluation
`Office of Drug Evaluation IV
`Center for Drug Evaluation and Research
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`Enclosures: Carton and Container Labeling
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`Reference ID: 3144803
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`

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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`JOEL SCHIFFENBAUER
`06/13/2012
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`Reference ID: 3144803
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