NDA 204168

ALLERGAN

FDA Drug Application

Application #204168

Documents

• Letter: 2013-07-29
• Letter: 2014-07-23
• Label: 2013-07-30
• Review: 2014-03-14
• Summary Review: 2014-03-14
• Letter: 2014-05-27
• Label: 2014-08-05
• Label: 2014-07-23
• Label: 2017-01-06
• Letter: 2017-01-10
• Label: 2017-12-21
• Letter: 2017-12-27
• Letter: 2019-10-08
• Label: 2019-11-26
• Medication Guide: 2019-11-26
• Letter: 2021-09-22
• Label: 2021-09-24
• Medication Guide: 2021-09-24

Application Sponsors

NDA 204168

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	EQ 20MG BASE	1	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	EQ 40MG BASE	1	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	EQ 80MG BASE	1	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	EQ 120MG BASE	1	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2013-07-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	2014-07-18	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-06-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-01-04	901 REQUIRED
LABELING; Labeling	SUPPL	5	AP	2017-12-19	901 REQUIRED
EFFICACY; Efficacy	SUPPL	6	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-09-20	901 REQUIRED

Submissions Property Types

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

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204168
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/204168s006lbl.pdf#page=28"]
            [products] => [{"drugName":"FETZIMA","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FETZIMA","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FETZIMA","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 80MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FETZIMA","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 120MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204168s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204168s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204168s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204168s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204168Orig1s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204168s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/25\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204168s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204168Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204168Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204168Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204168s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204168Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204168s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204168Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204168s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204168Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"06\/05\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/18\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204168s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204168Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"05\/23\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204168Orig1s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204168Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-10-07
        )

)