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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207968
Company: NOVARTIS

Medication Guide

Summary Review

Products on NDA 207968

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207968

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207968s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207968Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207968Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207968Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2020	SUPPL-9	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207968s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207968Orig1s009ltr.pdf
05/24/2019	SUPPL-8	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
07/25/2019	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207968s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207968Orig1s007ltr.pdf
12/12/2018	SUPPL-6	Labeling-Package Insert	Label Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s004, 207968Orig1s006ltr.pdf
08/03/2018	SUPPL-5	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-4	Efficacy-Labeling Change With Clinical Data	Label Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s004, 207968Orig1s006ltr.pdf
02/16/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s002ltr.pdf
05/11/2018	SUPPL-1	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s001ltr.pdf

Labels for NDA 207968

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2020	SUPPL-9	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207968s009lbl.pdf
07/25/2019	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207968s007lbl.pdf
05/24/2019	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s014,207968s008lbl.pdf
12/12/2018	SUPPL-6	Labeling-Package Insert			https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl
12/12/2018	SUPPL-4	Efficacy-Labeling Change With Clinical Data			https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl
08/03/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf
05/11/2018	SUPPL-1	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s001lbl.pdf
02/16/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s002lbl.pdf
05/18/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207968s000lbl.pdf

Therapeutic Equivalents for NDA 207968

JADENU SPRINKLE

GRANULE;ORAL; 90MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	213374	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	216229	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	214559	AUCTA
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	214180	TEVA PHARMS USA
JADENU SPRINKLE	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	Yes	AB	207968	NOVARTIS

GRANULE;ORAL; 180MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	213374	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	216229	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	214559	AUCTA
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	214180	TEVA PHARMS USA
JADENU SPRINKLE	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	Yes	AB	207968	NOVARTIS

GRANULE;ORAL; 360MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	213374	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	216229	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	214559	AUCTA
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	214180	TEVA PHARMS USA
JADENU SPRINKLE	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	Yes	AB	207968	NOVARTIS

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