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`DEPARTMENT OF HEALTH & HUMAN SERVICES
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 21-574
`
`Andrx Labs, Inc.
`
`Attention: Nicholas J. Farina, Ph.D.
`Vice President, Regulatory Affairs
`401 Hackensack Avenue, 9th 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 December 19, 2003, and February 9, and 18, 2004.
`The December 19, 2003, submission constituted a complete response to our October 17, 2003, action
`letter.
`
`We completed our review of this application as submitted with draft labeling, and it is approvable.
`Before the application may be approved, however, it will be necessary for you to provide the
`appropriate patent certifications.
`
`'
`Fortamet is an extended-release metformin tablet, as is Bristol-Myers Squibb‘s Glucophage XR.
`Glucophage XR was approved prior to your NDA submission. Fortamet and Glucophage XR are
`‘
`pharmaceutical equivalents (have the same active ingredient, dosage form, strength, route of
`administration); Section 5050) of the Federal Food, Drug and Cosmetic Act provides a procedure for
`approval of generic drug products that, among other things, have the same active ingredient, dosage
`form, strength, and route of administration as the innovator product, through the abbreviated new drug
`application process. This process requires that the applicant provide certifications to patents for the
`listed drug the applicant proposes to duplicate. To prevent applicants from using the 505(b)(2) process
`to avoid these statutory patent certification requirements, FDA has interpreted section 505(b)(2)(A) to
`require certifications for any patents listed for pharmaceutical equivalents. This interpretation is
`described in FDA‘s Draft Guidancefor Industry: Applications Covered by Section 5 05(b)(2) (October
`1999) which states that "[i]f there is a listed drug that is the pharmaceutical equivalent of the drug
`proposed in the 505(b)(2) application, the 505(b)(2) application should provide patent certifications for
`the patents listed for the pharmaceutically equivalent drug." Because of the statutory requirement,
`your 505(b)(2) NDA must contain patent certifications for those patents listed in Approved Drug
`Products with Therapeutic Equivalence Evaluations for Glucophage XR (NDA 21—202).
`
`If additional information relating to the safety or effectiveness of this drug becomes available, revision
`of the labeling may be required.
`
`

`

`NDA 21-574
`
`Page 2
`
`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 CFR 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.
`
`If you have any questions, please call Ms. Jena Weber, Regulatory Project Manager at 301-827—6422.
`
`Sincerely,
`
`.
`
`f‘
`
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`
`.
`
`.
`
`David G. Orloff, MD.
`Director
`
`Division of Metabolic and Endocrine Drug Products
`Office of Drug Evaluation II Center for Drug Evaluation
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Mary Parks
`2/20/04 06:13:52 PM
`for Dr. Orloff
`
`