NDA 022529

EISAI INC

FDA Drug Application

Application #022529

Documents

• Letter: 2012-06-27
• Letter: 2014-12-11
• Label: 2012-06-27
• Label: 2016-04-04
• Review: 2012-08-07
• Letter: 2017-05-25
• Letter: 2017-05-25
• Label: 2017-05-26
• Label: 2017-05-26

Application Sponsors

NDA 022529

EISAI INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

1

BELVIQ

LORCASERIN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-06-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-11-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-12-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-07-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-05-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-04-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-05-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	0
SUPPL	3	Null	15
SUPPL	4	Null	0
SUPPL	5	Null	6
SUPPL	6	Null	0
SUPPL	7	Null	15

CDER Filings

EISAI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22529
            [companyName] => EISAI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BELVIQ","activeIngredients":"LORCASERIN HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/23\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022529s005s007,208524s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022529s005s007,208524s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/09\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022529s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022529lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BELVIQ","submission":"LORCASERIN HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-05-23
        )

)