NDA 213137

GLOBAL BLOOD THERAPS

FDA Drug Application

Application #213137

Documents

• Label: 2019-11-25
• Letter: 2019-11-26
• Review: 2019-12-23
• Label: 2021-12-17
• Letter: 2021-12-22

Application Sponsors

NDA 213137

GLOBAL BLOOD THERAPS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	500MG	1	OXBRYTA	VOXELOTOR
002	TABLET;ORAL	300MG	1	OXBRYTA	VOXELOTOR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-11-25	PRIORITY
EFFICACY; Efficacy	SUPPL	6	AP	2021-12-17	PRIORITY

Submissions Property Types

ORIG	1	Null	10
SUPPL	6	Null	7

CDER Filings

GLOBAL BLOOD THERAPS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213137
            [companyName] => GLOBAL BLOOD THERAPS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXBRYTA","activeIngredients":"VOXELOTOR","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/17\/2021","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213137s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/213137s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/25\/2019","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\\\/2019\\\/213137s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/213137Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/213137Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/17\/2021","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213137s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213137Orig1s006ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-12-17
        )

)