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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-011
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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 February 5, 2009, received February 6,
`2009, 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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`This supplemental new drug application provides for a revised label configuration with a pull-out Drug
`Facts label for the non-child resistant (NCR) count size to be used with a redesigned bottle. The bottle
`was not submitted for approval as part of this supplement.
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`We have completed our review of this supplemental new drug application. This application is
`approved for the label for the NCR Aleve Liquid Gels 80-count package size, 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, 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 label (Aleve Liquid Gels 80-
`count carton label submitted February 5, 2009), 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-011.” Approval of this submission by FDA is not required before the
`labeling is used.
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`We remind you that the new bottle shape is not being reviewed or approved under this supplement.
`Assuming that the change in bottle shape meets the criteria outlined in 21 CFR 314.70, you should
`report this change in your next annual report. Otherwise, you should submit an appropriate
`supplemental new drug application for this change.
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`NDA 21-920/S-011
`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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`Joel Schiffenbauer, MD
`Deputy 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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`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
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`7/14/2009 11:53:09 AM
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