BLA 208471

SANOFI-AVENTIS US

FDA Drug Application

Application #208471

Documents

• Letter: 2020-03-23
• Label: 2020-03-23
• Review: 2020-03-23
• Medication Guide: 2020-03-23
• Other: 2020-04-07
• Letter: 2021-08-02
• Label: 2021-08-03
• Medication Guide: 2021-08-03
• Letter: 2022-06-13
• Label: 2022-06-15
• Medication Guide: 2022-06-15

Application Sponsors

BLA 208471

SANOFI-AVENTIS US

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;SUBCUTANEOUS	0.15MG/3ML (0.05MG/ML)	0	ADLYXIN	LIXISENATIDE
002	SOLUTION;SUBCUTANEOUS	0.3MG/3ML (0.1MG/ML)	0	ADLYXIN	LIXISENATIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2016-07-27	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2021-07-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-06-10	901 REQUIRED

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	6
SUPPL	5	Null	6

CDER Filings

SANOFI-AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208471
            [companyName] => SANOFI-AVENTIS US
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/208471Orig1s000lbl.pdf#page=31"]
            [products] => [{"drugName":"ADLYXIN","activeIngredients":"LIXISENATIDE","strength":"0.15MG\/3ML (0.05MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ADLYXIN","activeIngredients":"LIXISENATIDE","strength":"0.3MG\/3ML (0.1MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/27\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208471Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208471Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208471Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208471Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-07-27
        )

)