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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
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`Andrx Labs, Inc.
`Attention: Josephine Cucchiaro, Ph.D.
`Vice President, Regulatory Affairs
`401 Hackensack Avenue, 9th Floor
`Hackensack, NJ 07601
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`Dear Dr. Cucchiaro:
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`Please refer to your new drug application (NDA) dated December 17, 2002, received
`December 19, 2002, 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 February 26, and April 14, 19, and 22, 2004.
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`The February 26, 2004, submission constituted a complete response to our February 20, 2004, action
`letter.
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`This new drug application provides for the use of Fortamet (metformin HCl) Extended-Release Tablets
`as an adjunct to diet and exercise to lower blood glucose in patients with type 2 diabetes mellitus.
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`We completed our review of this application, as amended. It 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 labeling (text for the package insert and
`patient package insert) submitted April 27, 2004, and immediate carton and container labels (submitted
`February 9, 2004). 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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`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 NDA 21-574.” Approval of this submission by FDA is not required
`before the labeling is used.
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`

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`Deferred pediatric study under PREA for the treatment of pediatric patients with type 2
`diabetes mellitus in ages 10 to 16 years of age. Final Report Submission: December 31, 2004.
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`NDA 21-574
`Page 2
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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 deferring submission of your pediatric studies for ages 10 to 16 years until December 31, 2004.
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`Your deferred pediatric studies required under section 2 of the Pediatric Research Equity Act (PREA)
`are considered required postmarketing study commitments. The status of this postmarketing study shall
`be reported annually according to 21 CFR 314.81. This commitment is listed below.
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`Submit final study reports to this NDA. For administrative purposes, all submissions related to this
`pediatric postmarketing study commitment must be clearly designated “Required Pediatric Study
`Commitments.”
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`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`this division, the Division of Metabolic and Endocrine Drug Products, and two copies of both the
`promotional materials and the package insert directly to:
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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, please call Ms. Jena Weber, Regulatory Project Manager at 301-827-6422.
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`Sincerely,
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`{See appended electronic signature page}
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`David G. Orloff, M.D.
`Director
`Division of Metabolic and Endocrine Drug Products
`Office of Drug Evaluation II Center for Drug Evaluation
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`Division of Drug Marketing, Advertising,
`and Communications, HFD-42
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, MD 20857
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`Enclosure: Package Insert
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` 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/
`---------------------
`David Orloff
`4/27/04 05:02:24 PM
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