CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICATION NUMBER:
`
`125387Orig1s060
`
`
`
`
`
`Trade Name:
`
` EYLEA
`
`Aflibercept
`
`Regeneron Inc.
`
`August 12, 2019
`
`EYLEA is indicated for the treatment of patients with:
`
` ●
`
` Neovascular (Wet) Age-Related Macular Degeneration
`(AMD)
`● Macular Edema Following Retinal Vein Occlusion
`(RVO)
`● Diabetic Macular Edema (DME)
`● Diabetic Retinopathy (DR)
`
`Generic or Proper
`Name:
`
`Sponsor:
`
`
`
`
`Approval Date:
`
`
`Indication:
`
`
`Novartis Exhibit 2197.001
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`125387Orig1s060
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Medical Review(s)
`Chemistry Review(s)
`Environmental Assessment
`Pharmacology Review(s)
`Statistical Review(s)
`Microbiology / Virology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`X
`X
`
`
`
`
`
`X
`
`
`
`
`
`
`
`
`
`
`
`Novartis Exhibit 2197.002
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`125387Orig1s060
`
`
`APPROVAL LETTER
`
`Novartis Exhibit 2197.003
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`('71 11 U.S. FOOD & DRUG
`
`•,.,_-.,~l-
`
`<.i.,..,(:
`
`ADMINISTRATION
`
`BLA 125387/S-060
`
`Regeneron Pharmaceuticals, Inc.
`Attention: Candace Drumma
`Senior Manager Cmc Regulatory Affairs
`81 Columbia Turnpike, Bldg 85
`Rensselaer, NY 12144
`
`Dear Ms. Drumma:
`
`APPROVAL LETTER
`
`Please refer to your Supplemental Biologics License Application ( sBLA) dated and
`received April 12, 2019, and your amendments, submitted under section 351(a) of the
`Public Health Service Act for Eylea (aflibercept) injection, 2 mg/0.05 ml.
`
`We acknowledge receipt of your amendment dated April 12, 2019, which constituted a
`complete response to our October 15, 2018, action letter.
`
`This Prior Approval supplemental biologics license application provides for the addition
`of a new sterile 2 mg/0.05 ml single-dose pre-fjJled_s'J.r:iooeJ.e.E,S\_or:esentation for.(6,{i
`afliberceo:t...dtua_or:oduct. Ille PFS isJ iUed_a
`
`(b}(41' 1 - - - - - - -
`
`(b)(4)
`
`APPROVAL & LABELING
`
`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.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit, via
`the FDA automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 601.14(b)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabeling/default.htm,
`that is identical to the enclosed labeling (text for the prescribing information) and include
`the labeling changes proposed in any pending "Changes Being Effected" (CBE)
`supplements. Information on submitting SPL files using eLIST may be found in the
`guidance for industry titled SPL Standard for Content of Labeling Technical Qs and As
`at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatorylnformation/Guida
`nces/UC M072392 .pdf.
`
`U.S. Food & Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Novartis Exhibit 2197.004
`Regeneron v. Novartis, IPR2021-00816
`
`

`

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`Novartis Exhibit 2197.005
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`
` CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`125387Orig1s060
`
`
`LABELING
`
`Novartis Exhibit 2197.006
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`

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`Novartis Exhibit 2197.007
`Regeneron v. Novartis, IPR2021-00816
`
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`Regeneron v. Novartis, IPR2021-00816
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`Page 7 of 32
`
`Novartis Exhibit 2197.0013
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2197.0013
`Regeneron v. Novartis, IPR2021-00816
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