BLA 761089

TEVA PHARMS USA

FDA Drug Application

Application #761089

Documents

• Label: 2018-09-14
• Letter: 2018-09-18
• Review: 2018-10-16
• Letter: 2020-01-28
• Label: 2020-01-28
• Letter: 2021-09-28
• Label: 2021-09-29

Application Sponsors

BLA 761089

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

150MG/ML

0

AJOVY

FREMANEZUMAB-VFRM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-09-14	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2020-01-27	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-09-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	13	Null	7

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761089
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AJOVY","activeIngredients":"FREMANEZUMAB-VFRM","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/27\/2020","submission":"SUPPL-2","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761089s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761089s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761089s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761089Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761089Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/27\/2020","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761089s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761089Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-01-27
        )

)