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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206910
Company: NOVARTIS PHARMS CORP

Medication Guide

Products on NDA 206910

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JADENU	DEFERASIROX	90MG	TABLET;ORAL	Prescription	AB	Yes	No
JADENU	DEFERASIROX	180MG	TABLET;ORAL	Prescription	AB	Yes	No
JADENU	DEFERASIROX	360MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206910

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206910Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2020	SUPPL-15	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206910s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206910Orig1s015ltr.pdf
05/24/2019	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s014,207968s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206910Orig1s014, 207968Orig1s008ltr.pdf
07/26/2019	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206910Orig1s012ltr.pdf
12/12/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s009, 206910Orig1s011ltr.pdf
08/03/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s10,207968Orig1s005Ltr.pdf
12/12/2018	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s009, 206910Orig1s011ltr.pdf
02/16/2018	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s007ltr.pdf
05/11/2018	SUPPL-6	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s006ltr.pdf
01/26/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s005ltr.pdf
08/12/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206910s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206910Orig1s004ltr.pdf
10/22/2015	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003ltr.pdf
11/06/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/22/2015	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003ltr.pdf

Labels for NDA 206910

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2020	SUPPL-15	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206910s015lbl.pdf
07/26/2019	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s012lbl.pdf
05/24/2019	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s014,207968s008lbl.pdf
12/12/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s009s011lbl.pdf
12/12/2018	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s009s011lbl.pdf
08/03/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf
05/11/2018	SUPPL-6	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s006lbl.pdf
02/16/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s007lbl.pdf
01/26/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s005lbl.pdf
08/12/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206910s004lbl.pdf
10/22/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf
10/22/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf
03/30/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s000lbl.pdf

Therapeutic Equivalents for NDA 206910

JADENU

TABLET;ORAL; 90MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	208697	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	211824	ALEMBIC
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	210555	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	214341	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	214474	AUROBINDO PHARMA LTD
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	212669	CHARTWELL RX
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	210945	MSN
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	211395	MYLAN
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	212995	PIRAMAL HLTHCARE UK
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	211641	SUN PHARM
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	211383	ZYDUS PHARMS
JADENU	DEFERASIROX	90MG	TABLET;ORAL	Prescription	Yes	AB	206910	NOVARTIS PHARMS CORP

TABLET;ORAL; 180MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	208697	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	211824	ALEMBIC
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	210555	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	214341	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	214474	AUROBINDO PHARMA LTD
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	212669	CHARTWELL RX
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	210945	MSN
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	211395	MYLAN
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	212995	PIRAMAL HLTHCARE UK
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	211641	SUN PHARM
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	211383	ZYDUS PHARMS
JADENU	DEFERASIROX	180MG	TABLET;ORAL	Prescription	Yes	AB	206910	NOVARTIS PHARMS CORP

TABLET;ORAL; 360MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	208697	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	211824	ALEMBIC
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	210555	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	214341	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	214474	AUROBINDO PHARMA LTD
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	212669	CHARTWELL RX
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	210945	MSN
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	211395	MYLAN
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	212995	PIRAMAL HLTHCARE UK
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	211641	SUN PHARM
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	211383	ZYDUS PHARMS
JADENU	DEFERASIROX	360MG	TABLET;ORAL	Prescription	Yes	AB	206910	NOVARTIS PHARMS CORP

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