`
`
` NDA 202155/S-021
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
`
`
` Bristol-Myers Squibb Company
`
` Attention: Ambarish Singh, PhD
`
`
` Global Regulatory Lead Global Regulatory, Safety & Biometrics
`
` PO Box 4000
` Princeton, NJ 08543
`
`
`
`
`Dear Dr. Singh:
`
`
`
`
`
`Please refer to your supplemental new drug application (sNDA) dated August 28, 2018,
`
`
`
`received August 28, 2018, and your amendments, submitted under section 505(b) of the
`
`
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for Eliquis (apixaban) 2.5 mg and 5 mg
`
`tablets.
`
`
`
`
`
`
`
`This Prior Approval supplemental new drug application provides for revisions to the
`
`prescribing information pursuant to the Pregnancy Lactation and Labeling Rule, (PLLR).
`
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`
`
`
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`
`labeling.
`
`
`
`CONTENT OF LABELING
`
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`
`
`
`
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`
`
`
`
`
`the FDA automated drug registration and listing system (eLIST), as described at
`
`
`
`
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`
`
`Prescribing Information), with the addition of any labeling changes in pending “Changes
`
`
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
`
`
`
`in the enclosed labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for
`
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
`
`
`Reference ID: 4441621
`
`
`
`
`
`
`
`
` NDA 202155S-021
` Page 2
`
`
`
`
` The SPL will be accessible from publicly available labeling repositories.
`
`
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`
`
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`
`
`
`
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`
`
`
`
`format, that includes the changes approved in this supplemental application, as well as
`
`annual reportable changes. To facilitate review of your submission(s), provide a
`
`
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`
`
`Word version. The marked-up copy should provide appropriate annotations, including
`
`
`
`supplement number(s) and annual report date(s).
`
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`If you have any questions, please call Michael Monteleone, Associate Director for
`
`
`
`Labeling, at (301) 796-1952.
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Mary Ross Southworth, PharmD
`
`Deputy Director for Safety
`
`
`Division of Cardiovascular and Renal Products
`
`Office of Drug Evaluation I
`
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURE(S):
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4441621
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`MARY R SOUTHWORTH
`06/03/2019 08:18:41 AM
`
`Reference ID: 4441621
`
`(b
`
`
`
`