`RESEARCH
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`APPLICATION NUMBER:
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`202155Orig1s002
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`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`Food and Drug Administration
`Silver Spring, MD 20993
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 202155/S-002
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`Bristol-Myers Squibb Company
`Attention: Linda Gambone, Ph.D.
`Director, GRSS-US Liaison
`P.O. Box 4000
`Princeton, NJ 08543-4000
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`Dear Dr. Gambone:
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`We have received your Supplemental New Drug Application (sNDA) submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) for the following:
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`NDA Number: 202155
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`Supplement Number: 002
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`Product Name: Eliquis (apixaban) Tablets, 2.5 mg and 5 mg
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`Date of Submission: April 29, 2013
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`Date of Receipt: April 29, 2013
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`This supplemental application proposes labeling revisions.
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`Unless we notify you within 60 days of the receipt date that the application is not sufficiently
`complete to permit a substantive review, we will file the application on June 28, 2013, in
`accordance with 21 CFR 314.101(a).
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`If you have not already done so, promptly submit the content of labeling
`[21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Failure
`to submit the content of labeling in SPL format may result in a refusal-to-file action under
`21 CFR 314.101(d)(3).
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`SUBMISSION REQUIREMENTS
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`Please cite the application number listed above at the top of the first page of all submissions to
`this application. Send all submissions, electronic or paper, including those sent by overnight
`mail or courier, to the following address:
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`Reference ID: 3308765
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`NDA 202155/S-002
`Page 2
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Cardiovascular and Renal Products
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`All regulatory documents submitted in paper should be three-hole punched on the left side of the
`page and bound. The left margin should be at least three-fourths of an inch to assure text is not
`obscured in the fastened area. Standard paper size (8-1/2 by 11 inches) should be used; however,
`it may occasionally be necessary to use individual pages larger than standard paper size.
`Non-standard, large pages should be folded and mounted to allow the page to be opened for
`review without disassembling the jacket and refolded without damage when the volume is
`shelved. Shipping unbound documents may result in the loss of portions of the submission or an
`unnecessary delay in processing which could have an adverse impact on the review of the
`submission. For additional information, see
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/Drug
`MasterFilesDMFs/ucm073080.htm.
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`If you have questions, please contact:
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`Alison Blaus, RAC
`Regulatory Health Project Manager
`(301) 796-1138
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`Sincerely,
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`{See appended electronic signature page}
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`Edward Fromm, R.Ph., RAC
`Chief, Project Management Staff
`Division of Cardiovascular and Renal Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Reference ID: 3308765
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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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`EDWARD J FROMM
`05/17/2013
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`Reference ID: 3308765
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