NDA 214094

BIOCRYST PHARMACEUTICALS INC

FDA Drug Application

Application #214094

Documents

• Letter: 2020-12-07
• Label: 2020-12-10
• Review: 2020-12-30

Application Sponsors

NDA 214094

BIOCRYST PHARMACEUTICALS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE; ORAL	150MG	2	ORLADEYO	BEROTRALSTAT
002	CAPSULE; ORAL	110MG	2	ORLADEYO	BEROTRALSTAT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-12-03

STANDARD

Submissions Property Types

ORIG

1

Null

2

TE Codes

001	Prescription	TBD
002	Prescription	TBD

CDER Filings

BIOCRYST PHARMACEUTICALS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214094
            [companyName] => BIOCRYST PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORLADEYO","activeIngredients":"BEROTRALSTAT","strength":"150MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ORLADEYO","activeIngredients":"BEROTRALSTAT","strength":"110MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214094Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-03
        )

)