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`PublicHealthService
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`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 2 1-5 74
`
`Andrx Labs, Inc.
`Attention: Nicholas J. Farina, PhD.
`
`Vice President, Regulatory Affairs
`401 Hackensack Avenue, 9Lh Floor
`Hackensack, NJ 07601
`
`Dear Dr. Farina:
`
`Please refer to your new drug application (NDA) dated December 17, 2002, received
`December 19, 2002, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
`for-Fortamet (metformin extended—release) Tablets, 500 mg and 1000 mg.
`
`We acknowledge receipt of your submissions dated January 17, and 29, March 17, and 28, April 16,
`May 15, July 28, and September 30, 2003.
`
`We completed our review of this application, as amended, and it is approvable. Before the
`application may be approved, however, it will be necessary for you to provide sufficient data to
`_ demonstrate dosage form equivalence between the 500 mg and 1000 mg tablets.
`
`In addition, it will be necessary for you to submit revised labeling with the revisions indicated in the
`enclosed labeling. We are providing the following comments regarding your revisions:
`
`- Revise the language under CLINICAL PHARMACOLOGY section, Pharmacokinetics and
`Drug Metabolism subseCtion, Immediate-Release subsection.
`
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`'0 Under INDICATIONS AND USAGE section: Reference to =1:
`should be deleted.
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`NDA 21-574
`
`Page 2
`
`0 Under DOSAGE AND ADMINISTRATION section: Revise language.
`
`If additional information relating to the safety or effectiveness of this drug becomes available, revision
`of the labeling may be required.
`
`Submit revised labeling that incorporates the changes indicated in the enclosed labeling. A marked—up
`or highlighted copy as well as a clean copy of the labeling should be provided.
`
`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, HFD—S 10, and two copies of
`both the promotional materials and the package insert directly to:
`
`Division of Drug Marketing, Advertising, and Communications, HFD—42
`Food and Drug Administration
`5600 Fishers Lane
`
`Rockville, MD 20857
`
`Within 10 days after the date of this letter, you are required to amend this application, notify us of your
`intent to file an amendment, or follow one of your other options under 21 CFR 314.110. If you do not
`follow one of these options, we will consider your lack of response a request to withdraw the
`application under 21 CF R 314.65. Any amendment should respond to all the deficiencies listed. We
`will not process a partial reply as a major amendment nor will the review clock be reactivated until all
`deficiencies have been addressed.
`
`The drug product may not be legally marketed until you have been notified in writing that the
`application is approved.
`
`
`
`NDA 2 1 -5 74
`
`Page 3
`
`If you have any questions, please call Ms. Jena Weber, Regulatory Project Manager, at 301-827-6422.
`
`Sincerely,
`
`{See affgL/edelectronicsignaturepage}
`
`David G. Orloff, MD.
`Director
`
`Division of Metabolic and Endocrine Drug Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`ENCLOSURE (draft labeling)
`
`
`
`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
`
`10/17/03 01:15:44 PM
`
`
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