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` DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
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`Rockville, MD 20857
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`NDA 21-574/S-010
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` Andrx Pharmaceuticals, LLC
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`Attention: Ms. Janet Vaughn
`Sr. Director, Regulatory Affairs
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`2945 West Corporate Lakes Blvd.
`Weston, FL 33331
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`Dear Ms.Vaughn:
`
`
`Please refer to your supplemental new drug application dated January 18, 2008, received
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`January 22, 2008, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Fortamet (metformin HCl extended-release) Tablets.
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`We acknowledge receipt of your submission dated July 17, 2008.
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`This supplemental application is in response to our supplement request letter dated
`November 19, 2007, and proposes labeling revisions to the DESCRIPTION, INDICATIONS AND
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` USAGE, and PRECAUTIONS sections of the package insert.
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`We have completed our review of this application, as amended. This application is approved, effective
`on the date of this letter, for use as recommended in the agreed-upon labeling text.
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` As soon as possible, but no later than 14 days from the date of this letter, please submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format as described at
` http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed labeling (text for the
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` package insert) submitted July 17, 2008). Upon receipt, we will transmit that version to the National
` Library of Medicine for public dissemination. For administrative purposes, please designate this
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`submission, “SPL for approved NDA 21-574.”
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` We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`NDA 21-574/S-010
`Page 2
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`If you have any questions, please call Ms. Jena Weber, Regulatory Project Manager, at
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`301-796-1306.
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`Sincerely,
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`{See appended electronic signature page}
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`Mary H. Parks, M.D.
`Director
`Division of Metabolism & Endocrinology Products
`Office of Drug Evaluation II
`
`Center for Drug Evaluation and Research
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`Enclosure (package insert)
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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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`---------------------
`Mary Parks
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`7/29/2008 09:14:08 AM
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