NDA 215498

ALBIREO PHARMA INC

FDA Drug Application

Application #215498

Documents

• Label: 2021-07-21
• Letter: 2021-07-21
• Review: 2021-08-18
• Letter: 2022-10-24
• Label: 2022-10-26

Application Sponsors

NDA 215498

ALBIREO PHARMA INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	400MCG	0	BYLVAY	ODEVIXIBAT
002	CAPSULE;ORAL	1200MCG	0	BYLVAY	ODEVIXIBAT
003	PELLETS;ORAL	200MCG	0	BYLVAY	ODEVIXIBAT
004	PELLETS;ORAL	600MCG	0	BYLVAY	ODEVIXIBAT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-07-20	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2022-10-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6

CDER Filings

ALBIREO PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215498
            [companyName] => ALBIREO PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BYLVAY","activeIngredients":"ODEVIXIBAT","strength":"400MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BYLVAY","activeIngredients":"ODEVIXIBAT","strength":"1200MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BYLVAY","activeIngredients":"ODEVIXIBAT","strength":"200MCG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BYLVAY","activeIngredients":"ODEVIXIBAT","strength":"600MCG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/20\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215498s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/20\/2021","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\\\/2021\\\/215498s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215498Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-07-20
        )

)