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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 201281/S-002
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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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`Boehringer Ingelheim Pharmaceuticals, Inc.
`Attention: Dawn Collette
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`Associate Director, CMC Regulatory Affairs
`900 Ridgebury Road/ P.O. Box 368
`Ridgefield, CT 06877-0368
`
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`Dear Ms. Collette:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received March 27,
`2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Jentadueto (linagliptin and metformin hydrochloride) tablets, 2.5 mg/500 mg, 2.5 mg/850 mg,
`and 2.5 mg/1000 mg.
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`We acknowledge receipt of your amendment dated June 13, 2012.
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`This “Prior Approval” supplemental new drug application proposes to add a picture of the tablet
`to the carton and container labels to provide better differentiation.
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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 carton and immediate
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`container labels submitted on June 13, 2012, as soon as they are available, but no more than 30
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`days after they are 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 201281/S-002.” Approval of this submission by FDA is not required before the labeling is
`used.
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`Reference ID: 3194127
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` NDA 201281/S-002
`Page 2
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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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`ENCLOSURES:
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`Carton and Container Labeling
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`Reference ID: 3194127
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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
`09/25/2012
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`Reference ID: 3194127
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