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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 21-926/S-001
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` POZEN, Inc.
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`Attention: Paul A. Ossi, Senior Vice President, Regulatory Affairs
`1414 Raleigh Road, Suite 400
`Chapel Hill, NC 27517
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`Dear Mr. Ossi:
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`Please refer to your supplemental new drug application dated April 17, 2008, received April 18, 2008,
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`submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Treximet™
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`(sumatriptan 85 mg and naproxen sodium 500 mg) Tablets.
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`This “Changes Being Effected in 30 days” supplemental new drug application provides for a
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`FTCR compact bottle sample pack containing 2 tablets.
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`We completed our review of this supplemental new drug application and it is approved.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the submitted carton and
`immediate container labels as soon as they are available, but no more than 30 days after they are
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`printed. Please submit these labels electronically according to the guidance for industry titled
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`Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product
`Applications and Related Submissions Using the eCTD Specifications (October 2005). Alternatively,
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`you may submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
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`similar material. For administrative purposes, designate this submission “Final Printed Carton and
`Container Labels for approved NDA 21-926.” Approval of this submission by FDA is not required
`before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render the
`product misbranded and an unapproved new drug.
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`We remind you that you must comply with the reporting requirements for an approved NDA (21 CFR
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`314.80 and 314.81).
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`If you have any questions, call Teshara G. Bouie, Regulatory Health Project Manager, at (301) 796-
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`1649.
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`Sincerely,
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`(b) (4)
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`NDA 21-926/S-001
`Page 2
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` {See appended electronic signature page}
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`James D. Vidra, Ph.D.
`Branch Chief
`Branch VII, Division of Post-Marketing Evaluation
`Office of New Drug Quality Assessment
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`Center for Drug Evaluation and Research
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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.
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`/s/
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`Hasmukh Patel
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`10/17/2008 05:04:43 PM
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`Signed for Dr. James Vidra.
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