BLA 761063

ELI LILLY AND CO

FDA Drug Application

Application #761063

Documents

• Label: 2018-09-28
• Letter: 2018-10-01
• Review: 2018-11-07
• Label: 2019-06-05
• Letter: 2019-06-05
• Letter: 2019-12-06
• Label: 2019-12-06
• Letter: 2022-05-25
• Label: 2022-05-26

Application Sponsors

BLA 761063

ELI LILLY AND CO

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

120MG/ML

0

EMGALITY

GALCANEZUMAB-GNLM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-09-27	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2019-06-04	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2019-12-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-05-24	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7

CDER Filings

ELI LILLY AND CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761063
            [companyName] => ELI LILLY AND CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMGALITY","activeIngredients":"GALCANEZUMAB-GNLM","strength":"120MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/05\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761063s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761063s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761063s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761063s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761063Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761063Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/05\/2019","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761063s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761063Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"06\/04\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761063s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761063Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-05
        )

)