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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-006
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`Andrx Labs, L.L.C. (d/b/a Watson Laboratories – Florida)
`Attention: Kemi Y. Onayemi, Ph.D.
`Specialist, Regulatory Affairs
`4955 Orange Drive
`Ft. Lauderdale, FL 33314
`
`Dear Dr. Onayemi:
`
`Please refer to your supplemental new drug application dated March 22, 2007, received
`March 23, 2007, 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 submission dated April 3, 2007.
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`This supplemental application, submitted as “Supplement - Changes Being Effected” proposes
`revisions to the CONTRAINDICATIONS, DOSAGE AND ADMINISTRATION and STORAGE
`sections of the package insert, editorial changes, and revisions to the patient package insert.
`
`We completed our review of this supplemental new drug application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the final printed labeling (FPL)
`submitted on April 3, 2007.
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`Within 21 days of the date of this letter, submit content of 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 in content to the enclosed labeling (text for the package insert and patient package insert
`submitted April 3, 2007). Upon receipt and verification, we will transmit that version to the National
`Library of Medicine for public dissemination.
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`Submit final printed labeling (FPL) in electronic format that is identical to the enclosed labeling as
`soon as it is available. For administrative purposes, designate this submission "FPL for approved
`supplement NDA 21-574/S-006.” Approval of this submission by FDA is not required before the
`labeling is used.
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`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred.
`We are waiving the pediatric study requirement for this application.
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`

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`NDA 21-574/S-006
`Page 2
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`We remind you that you must comply with the reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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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,
`
`{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/patient 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/
`---------------------
`Mary Parks
`4/19/2007 06:43:43 AM
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