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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021920/S-013
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`Food and Drug Administration
`Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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`Banner Pharmacaps Inc.
`Attention: Vandana Garikipati, MS, RAC
`Manager, Regulatory Affairs
`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 February 9, 2010,
`received February 17, 2010, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Aleve (naproxen sodium) capsules, 220 mg.
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`We acknowledge receipt of your correspondence dated August 05, 2010.
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`This “Changes Being Effected” supplemental new drug application provides for revised labeling
`in accordance with the April 29, 2009 final monograph for Organ-Specific Warnings; Internal
`Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use.
`This supplemental NDA also provides for the removal of the directions statement “do not take
`longer than 10 days, unless directed by a doctor (see warnings)” in response to the September 04,
`2009 general advice letter from FDA.
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`We have completed our review of this application. 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 remind you of your agreement, stated in your submission dated August 5, 2010, that a lot
`number designation will be included on the final printed immediate container (bottle) labels for
`all stock-keeping-units (SKUs) in accordance with 21 CFR 201.18.
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`LABELING
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`Submit final printed labeling, with the revision listed above, 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 (40-count (representative of the 20-, 40-, and 80-count) carton and
`immediate container labels, and 160-count immediate container (bottle) label submitted February
`9, 2010), and must be in the “Drug Facts” format (21 CFR 201.66), where applicable.
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`

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`NDA 021920/S-013
`Page 2
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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-013.” Approval of this
`submission by FDA is not required before the labeling is used.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA, to
`CDERMedWatchSafetyAlerts@fda.hhs.gov, and to the following address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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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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`If you have any questions, call 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 Division Director
`Division of Nonprescription Clinical Evaluation
`Office of Drug Evaluation IV
`Center for Drug Evaluation and Research
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`Enclosure: Labeling
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`Application
`Type/Number
`--------------------
`NDA-21920
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`Submission
`Type/Number
`--------------------
`SUPPL-13
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`Submitter Name
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`Product Name
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`------------------------------------------
`--------------------
`NAPROXEN SODIUM
`BANNER
`PHARMACAPS INC CAPSULES 220MG
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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
`08/12/2010
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