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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-574/S-005
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`Andrx Labs L.L.C.
`Attention: Samuel Swetland
`Manager, Regulatory Affairs
`4955 Orange Drive
`Ft. Lauderdale, FL 33314
`
`Dear Mr. Swetland:
`
`Please refer to your supplemental new drug application dated August 5, 2005, received
`August 8, 2005, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`for Fortamet® (metformin HCl extended-release tablets) 500 mg and 1000 mg.
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`We acknowledge receipt of your submissions dated January 30, and February 7, 2006.
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`This supplemental application, submitted as “Supplement - Changes Being Effected,” proposes to add
`a statement to the sample cartons to strengthen the Warnings statement by referring to the boxed
`warning in the full prescribing information. Additional editorial changes have also been specified.
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`We 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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`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the immediate
`sample cartons) submitted February 7, 2006.
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`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies
`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount
`15 of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission "FPL for approved supplement NDA 21-574/S-005.” Approval of this submission by
`FDA is not required before the labeling is used.
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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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`NDA 21-574/S-005
`Page 2
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`If you have any questions, please call Ms. Jena Weber, Regulatory Project Manager, at
`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.
`Acting Director
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`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.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Mary Parks
`2/8/2006 12:12:49 PM
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