ALBIREO PHARMA INC FDA Approval NDA 215498

NDA 215498

ALBIREO PHARMA INC

FDA Drug Application

Application #215498

Documents

Label2021-07-21
Letter2021-07-21
Review2021-08-18

Application Sponsors

NDA 215498ALBIREO PHARMA INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL400MCG0BYLVAYODEVIXIBAT
002CAPSULE;ORAL1200MCG0BYLVAYODEVIXIBAT
003PELLETS;ORAL200MCG0BYLVAYODEVIXIBAT
004PELLETS;ORAL600MCG0BYLVAYODEVIXIBAT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-07-20PRIORITY

Submissions Property Types

ORIG1Null7

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
        )

)

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