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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022350/S-009
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Bristol-Myers Squibb Company
`Attention: Pamela J. Smith, M.D.
`Group Director, GRS
`P.O. Box 4000
`Princeton, NJ 08543
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`Dear Dr. Smith:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received September
`16, 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Onglyza (saxagliptin) Tablets, 2.5mg and 5mg.
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`We acknowledge receipt of your amendments dated October 27, and November 18, 2011, and
`February 10, 2012. The February 10, 2012, amendment was a general correspondence to request
`removal of the 2.5 mg labels from this supplement.
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`This Prior Approval supplemental new drug application provides for revisions to the Carton label
`(5 mg sample carton) and Container label (5 mg sample blister).
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the enclosed carton and
`immediate container labels, as soon as they are available, but no more than 30 days after they are
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`printed.
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`Please submit these labels electronically according to the guidance for industry titled “Providing
`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
`and Related Submissions Using the eCTD Specifications (June 2008).” Alternatively, you may
`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
`similar material. For administrative purposes, designate this submission “Product
`Correspondence – Final Printed Carton and Container Labels for approved
`NDA 022350/S-009.” Approval of this submission by FDA is not required before the labeling is
`used.
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`Reference ID: 3101150
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` NDA 022350/S-009
`Page 2
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on page 2 of the form. For more information about submission of
`promotional materials to the Office of Prescription Drug Promotion (OPDP), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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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, call Raymond Chiang, Regulatory Project Manager, at (301) 796-
`1940.
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`Sincerely,
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`{See appended electronic signature page}
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`Mary Parks, M.D.
`Director
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`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Carton and Container Labeling
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`Reference ID: 3101150
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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/
`----------------------------------------------------
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`MARY H PARKS
`03/13/2012
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`Reference ID: 3101150
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