NDA 211855

BIOGEN

FDA Drug Application

Application #211855

Documents

• Label: 2019-10-30
• Letter: 2019-11-01
• Review: 2020-04-21
• Letter: 2020-08-25
• Label: 2020-09-02
• Label: 2021-02-01
• Letter: 2021-02-01
• Label: 2022-02-11
• Letter: 2022-02-14
• Letter: 2022-09-30
• Letter: 2022-10-03
• Label: 2022-10-03
• Letter: 2023-01-17
• Label: 2023-01-19

Application Sponsors

NDA 211855

BIOGEN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, DELAYED RELEASE;ORAL

231MG

1

VUMERITY

DIROXIMEL FUMARATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-08-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-01-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-02-10	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2022-11-16	N/A

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	10	Null	15

CDER Filings

BIOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211855
            [companyName] => BIOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"VUMERITY","activeIngredients":"DIROXIMEL FUMARATE","strength":"231MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/21\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211855s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211855s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211855s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/29\/2019","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\\\/2019\\\/211855s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211855Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211855Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/21\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211855s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211855Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-08-21
        )

)