BLA 761136

CELGENE CORP

FDA Drug Application

Application #761136

Documents

• Label: 2019-11-08
• Letter: 2019-11-12
• Review: 2019-12-19
• Label: 2020-04-06
• Letter: 2020-04-06
• Review: 2020-10-08
• Letter: 2022-07-11
• Label: 2022-07-11

Application Sponsors

BLA 761136

CELGENE CORP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;SUBCUTANEOUS	25MG/VIAL	0	REBLOZYL	LUSPATERCEPT-AAMT
002	POWDER;SUBCUTANEOUS	75MG/VIAL	0	REBLOZYL	LUSPATERCEPT-AAMT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-11-08	PRIORITY
EFFICACY; Efficacy	ORIG	2	AP	2020-04-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-07-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	2
SUPPL	6	Null	6

CDER Filings

CELGENE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761136
            [companyName] => CELGENE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"REBLOZYL","activeIngredients":"LUSPATERCEPT-AAMT","strength":"25MG\/VIAL","dosageForm":"POWDER;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"REBLOZYL","activeIngredients":"LUSPATERCEPT-AAMT","strength":"75MG\/VIAL","dosageForm":"POWDER;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/03\/2020","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761136orig2lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761136lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/03\/2020","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761136orig2lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761136Orig2s000ltr.pdf\"}]","notes":">"},{"actionDate":"11\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761136lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761136Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761136Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-03
        )

)