NDA 205494

GENZYME CORP

FDA Drug Application

Application #205494

Documents

• Letter: 2014-08-20
• Label: 2014-08-22
• Review: 2014-09-17
• Summary Review: 2014-09-17
• Medication Guide: 2018-02-28
• Label: 2018-08-31
• Letter: 2018-09-13
• Medication Guide: 2018-11-01

Application Sponsors

NDA 205494

GENZYME CORP

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 84MG BASE

1

CERDELGA

ELIGLUSTAT TARTRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2014-08-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-05-11	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2018-08-29	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

GENZYME CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205494
            [companyName] => GENZYME CORP
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/205494s003lbl.pdf#page=19"]
            [products] => [{"drugName":"CERDELGA","activeIngredients":"ELIGLUSTAT TARTRATE","strength":"EQ 84MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/29\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205494s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205494s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205494Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/19\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205494Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205494Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205494Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205494Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/29\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205494s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205494Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"05\/11\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-08-29
        )

)