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` DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
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`Rockville, MD 20857
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`NDA 21-920/S-010
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`Banner Pharmacaps Inc.
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`Attention: Vandana Garikipati, MS, RAC
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`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 dated October 16, 2008, received October 17,
`2008, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Aleve Liquid
`Gels (220 mg naproxen sodium capsules).
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`We acknowledge receipt of your correspondences dated March 20, and April 3, 2009 providing further
`explanation of the representative labeling.
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`This supplemental new drug application (NDA) provides for the revised cardiovascular warning
`statement “When using this product the risk of heart attack or stroke may increase if you use more than
`directed or for longer than directed” and the addition of the warning statement “Ask a doctor before
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`use if you have asthma” to the Drug Facts label in response to the September 19, 2008 supplemental
`labeling request letters.
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`We have completed our review of this supplemental new drug application. This application is
`approved for the Aleve Liquid Gels 40-count (representative of the 20-, 40- and 80-count) and 160-
`count package sizes, effective on the date of this letter, for use as recommended in the agreed-upon
`labeling text.
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`Submit final printed labeling for all represented stock keeping units, 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 labels (Aleve Liquid Gels 40-count carton label (representative of the 20-, 40-, and 80-count
`carton) and 160-count immediate container label submitted October 16, 2008), and must be in the
`“Drug Facts” format (21 CFR 201.66), where applicable.
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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 (October 2005). 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 21-920/S-010.” Approval of this submission by FDA is not required before the
`labeling is used.
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`

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`NDA 21-920/S-010
`Page 2
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`If you 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 an electronic copy of the letter to
`both this NDA and to the following address:
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`MedWatch
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`Food and Drug Administration
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`Suite 12B05
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`5600 Fishers Lane
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`Rockville, MD 20857
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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 Neel Patel, Regulatory Project Manager, at (301) 796-0970.
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`Sincerely,
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`{See appended electronic signature page}
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`Andrea Leonard-Segal, MD
`Director
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`Division of Nonprescription Clinical Evaluation
`Office of Nonprescription Products
`Center for Drug Evaluation and Research
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`Enclosure
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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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`---------------------
`Andrea Segal
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`4/15/2009 08:17:59 PM
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