NDA 022161

ASTELLAS

FDA Drug Application

Application #022161

Documents

• Letter: 2009-03-19
• Letter: 2009-12-31
• Letter: 2011-09-28
• Letter: 2011-10-04
• Letter: 2014-01-07
• Label: 2008-04-16
• Label: 2011-09-29
• Label: 2011-09-30
• Label: 2014-01-10
• Review: 2008-06-02
• Other Important Information from FDA: 2014-02-07
• Letter: 2008-04-16
• Letter: 2011-09-28
• Letter: 2011-09-28
• Letter: 2014-01-14
• Letter: 2014-09-23
• Label: 2009-04-03
• Label: 2009-12-30
• Label: 2011-09-29
• Label: 2011-09-29
• Label: 2014-01-07
• Label: 2014-09-22
• Label: 2017-01-17
• Letter: 2017-01-19
• Label: 2018-05-31
• Letter: 2018-06-01

Application Sponsors

NDA 022161

ASTELLAS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

0.4MG/5ML (0.08MG/ML)

1

LEXISCAN

REGADENOSON

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2008-04-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2009-03-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	2009-12-23	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2014-03-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2011-09-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2011-09-23	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2011-09-23	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2011-09-30	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2014-01-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-09-19	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2017-01-17	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-05-31	STANDARD

Submissions Property Types

SUPPL	4	Null	6
SUPPL	5	Null	0
SUPPL	6	Null	6
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	15	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22161
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEXISCAN","activeIngredients":"REGADENOSON","strength":"0.4MG\/5ML (0.08MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/31\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022161s015lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2017","submission":"SUPPL-13","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022161s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022161s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022161s011lbledt.pdf\"}]","notes":""},{"actionDate":"01\/09\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022161s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022161s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2011","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022161s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2011","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022161s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2011","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022161s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2009","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022161s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/17\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022161s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022161lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEXISCAN","submission":"REGADENOSON","actionType":"0.4MG\/5ML (0.08MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-05-31
        )

)