Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 75MG | 2 | PRALUENT | ALIROCUMAB |
| 002 | INJECTABLE;INJECTION | 150MG | 2 | PRALUENT | ALIROCUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-07-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2017-07-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2017-09-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2018-08-22 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2018-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-11-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2019-04-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2019-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2020-03-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2021-04-01 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2021-04-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 15 |
CDER Filings
SANOFI AVENTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 125559
[companyName] => SANOFI AVENTIS
[docInserts] => ["",""]
[products] => [{"drugName":"PRALUENT","activeIngredients":"ALIROCUMAB","strength":"75MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PRALUENT","activeIngredients":"ALIROCUMAB","strength":"150MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"03\/10\/2020","submission":"SUPPL-24","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125559s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2020","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125559s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2019","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125559s019s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2019","submission":"SUPPL-19","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125559s019s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125559s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2018","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125559s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125559s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125559s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2017","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125559s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2017","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125559s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125559s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125559Orig1s000lbledt.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125559Orig1s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125559Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125559Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/10\/2020","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125559s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125559Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"04\/26\/2019","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125559s019s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"04\/26\/2019","submission":"SUPPL-19","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125559s019s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/06\/2018","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125559s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125559Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"07\/20\/2018","submission":"SUPPL-15","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125559s015lbl.pdf\"}]","notes":">"},{"actionDate":"08\/22\/2018","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125559s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125559Orig1s014Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/125559Orig1s014TOC.cfm\"}]","notes":">"},{"actionDate":"09\/20\/2017","submission":"SUPPL-6","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125559s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125559Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"07\/27\/2017","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125559s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125559Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"04\/24\/2017","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125559s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125559Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-10
)
)