BLA 125249

REGENERON PHARMACEUTICALS

FDA Drug Application

Application #125249

Documents

• Letter: 2008-04-09
• Label: 2008-03-11
• Review: 2008-05-02
• Label: 2020-07-24
• Letter: 2020-07-27
• Label: 2020-12-21
• Letter: 2020-12-22
• Label: 2021-03-19
• Letter: 2021-03-22

Application Sponsors

BLA 125249

REGENERON PHARMACEUTICALS

Marketing Status

• Prescription: 001

Application Products

001

VIAL; SINGLE-USE

220MG

0

ARCALYST

RILONACEPT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2008-02-27	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2010-09-30	STANDARD
LABELING; Labeling	SUPPL	45	AP	2020-02-12	STANDARD
EFFICACY; Efficacy	SUPPL	47	AP	2020-12-18	PRIORITY
EFFICACY; Efficacy	SUPPL	49	AP	2021-03-18	PRIORITY

Submissions Property Types

ORIG	1	Null	25
SUPPL	45	Null	7
SUPPL	47	Null	6
SUPPL	49	Null	30

CDER Filings

REGENERON PHARMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125249
            [companyName] => REGENERON PHARMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARCALYST","activeIngredients":"RILONACEPT","strength":"220MG","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125249s045lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125249lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/27\/2008","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125249lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125249s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2008\\\/125249s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-45","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125249s045lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125249Orig1s045ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2010","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-12
        )

)