AGIOS PHARMACEUTICALS INC FDA Approval NDA 216196

NDA 216196

AGIOS PHARMACEUTICALS INC

FDA Drug Application

Application #216196

Documents

Label2022-02-17
Letter2022-02-18
Review2022-03-17

Application Sponsors

NDA 216196AGIOS PHARMACEUTICALS INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL5MG0PYRUKYNDMITAPIVAT
002TABLET;ORAL20MG0PYRUKYNDMITAPIVAT
003TABLET;ORAL50MG0PYRUKYNDMITAPIVAT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-02-17PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

AGIOS PHARMACEUTICALS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216196
            [companyName] => AGIOS PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYRUKYND","activeIngredients":"MITAPIVAT","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PYRUKYND","activeIngredients":"MITAPIVAT","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PYRUKYND","activeIngredients":"MITAPIVAT","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/17\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216196s000lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216196s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/17\/2022","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\\\/2022\\\/216196s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216196Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-02-17
        )

)

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