`
`Drugs@FDA: FDA-Approved Drugs
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`Biologic License Application (BLA): 208471
`Company: SANOFI-AVENTIS US
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=208471)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208471s007lbl.pdf#page=24)
`This Former NDA Was Deemed To Be a BLA on March 23, 2020. (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla)
`
`Products on BLA 208471
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`CSV
`
`Excel
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`Drug Name
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`Active Ingredients
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`Strength
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`Dosage Form/Route
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`Marketing Status
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`TE Code
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`RLD
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`ADLYXIN
`
`ADLYXIN
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`LIXISENATIDE
`
`LIXISENATIDE
`
`Showing 1 to 2 of 2 entries
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`0.15MG/3ML (0.05MG/ML)
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`SOLUTION;SUBCUTANEOUS
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`0.3MG/3ML (0.1MG/ML)
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`SOLUTION;SUBCUTANEOUS
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`Prescription
`
`Prescription
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`None
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`None
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`No
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`No
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`RS
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`No
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`No
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`Approval Date(s) and History, Letters, Labels, Reviews for BLA 208471
`
`Original Approvals or Tentative Approvals
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`CSV
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`Excel
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`
`Action
`Date
`
`Submission
`
`07/27/2016
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`ORIG-1
`
`Action
`Type
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`Approval
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`Submission
`Classi cation
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`Review
`Priority;
`Orphan
`Status
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`N/A
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`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208471Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208471Orig1s000TOC.cfm)
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`Showing 1 to 1 of 1 entries
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`Supplements
`
`CSV
`
`Excel
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`
`Action Date
`
`Submission
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`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`09/28/2023
`
`SUPPL-7
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208471s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208471Orig1s007ltr.pdf)
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`06/10/2022
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`SUPPL-5
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`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208471Orig1s005ltr.pdf)
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`07/30/2021
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`SUPPL-4
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`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208471s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208471Orig1s004ltr.pdf)
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`Showing 1 to 3 of 3 entries
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`Labels for BLA 208471
`
`
`
`
`
`
`
`Novo Nordisk Exhibit 2456
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`Biologic License Application (BLA): 208471
`Company: SANOFI-AVENTIS US
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=208471)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208471s007lbl.pdf#page=24)
`This Former NDA Was Deemed To Be a BLA on March 23, 2020. (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla)
`
`Products on BLA 208471
`
`Approval Date(s) and History, Letters, Labels, Reviews for BLA 208471
`
`Labels for BLA 208471
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`09/28/2023
`
`SUPPL-7
`
`06/10/2022
`
`SUPPL-5
`
`06/10/2022
`
`SUPPL-5
`
`07/30/2021
`
`SUPPL-4
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Patient
`Package Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208471s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208471s004lbl.pdf)
`
`07/27/2016
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf)
`
`Showing 1 to 5 of 5 entries
`
`
`
`
`
`
`
`Note
`
`Novo Nordisk Exhibit 2456
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`