CENTER FOR DRUG EVALUATION AND
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`RESEARCH
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`APPLICA TION NUMBER:
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`2 1 -92 0
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`APPROVAL LETTER
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`PublicHealthService
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`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21 —920
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`Banner Pharrnacaps Inc.
`Attention: Shelly Meachum
`Director, Regulatory Affairs
`4125 Premier Drive
`
`High Point, NC 27265
`
`Dear Ms. Meachum:
`
`Please refer to your new drug application (NDA) dated April 15, 2005, received April 18, 2005,
`submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for naproxen sodium
`220 mg capsules.
`
`We acknowledge receipt of your submissions dated May 3, July 28, July 29, and October 14, 2005, and
`January 4, January 5, and February 9, 2006.
`
`This new drug application provides for the use of naproxen sodium 220 mg capsules for relief of minor
`aches and pains due to headache, backache, muscular aches, common cold, arthritis, toothache,
`menstrual cramps, and fever.
`
`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 submitted final printed labeling (immediate container and
`carton labels submitted February 9, 2006).
`
`If you choose to use a proprietary name for this product, the name and its‘use in the labels must
`conform to the specifications under 21 CFR 201.10 and 201.15. We recommend that you submit any
`proprietary name to the Agency for our review prior to its implementation.
`
`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We
`reference the partial waiver granted on December 2, 2005 for the pediatric study requirement for ages
`less than 6 months of age for this application. We also reference the deferral granted on December 2, g
`2005 for the pediatric study requirement for ages 6 months to 11 years of age for this application.
`
`Your deferred pediatric studies required under section 2 of the Pediatric Research Equity Act (PREA)
`are considered required postmarketing study commitments. The status of this postmarketing study shall
`be reported annually according to 21 CFR 314.81. This commitment is listed below;
`
`1. Deferred pediatric study under PREA for the treatment of fever, minor aches and pains due to
`the common cold, flu, sore throat, headaches, and toothaches in pediatric patients ages 6 month
`to 11 years of age.
`
`Your final report submission is due February 18, 2009.
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`

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`NDA 21-920
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`Page 2
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`Submit your final study reports to this NDA. For administrative purposes, all submissions related to
`this pediatric postrnarketing study commitment must be clearly designated “Required Pediatric Study
`Commitments”. Please submit your pediatric drug development plans within 120 days from the date
`of this letter.
`
`In addition, we request that you submit one copy of the introductory promotional materials you
`propose to use for this product. Submit all proposed materials in draft or mock-up form, not final print
`to the Division of Nonprescription Clinical Evaluation.
`
`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 Neel Patel, Regulatory Project Manager at (301) 796-0970.
`
`Sincerely,
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`Andrea Leonard—Segal, M.D.
`Acting Director
`'
`Division of Nonprescription Clinical Evaluation
`Office of Nonprescription Products
`Center for Drug Evaluation and Research
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`Enclosure
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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.
`
`Andrea Segal
`2/17/2006 02:39:32 PM
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`