Details for New Drug Application (NDA): 207968

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NDA 207968 describes JADENU SPRINKLE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the JADENU SPRINKLE profile page.

The generic ingredient in JADENU SPRINKLE is deferasirox. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

Summary for 207968

Tradename:	JADENU SPRINKLE
Applicant:	Novartis
Ingredient:	deferasirox
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 207968

Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity

Suppliers and Packaging for NDA: 207968

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968	NDA	Novartis Pharmaceuticals Corporation	0078-0713	0078-0713-15	30 PACKET in 1 CARTON (0078-0713-15) / 1 GRANULE in 1 PACKET (0078-0713-19)
JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968	NDA	Novartis Pharmaceuticals Corporation	0078-0720	0078-0720-15	30 PACKET in 1 CARTON (0078-0720-15) / 1 GRANULE in 1 PACKET (0078-0720-19)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	90MG
Approval Date:	May 18, 2017	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 24, 2022
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING FOR SAFETY & EFFICACY STUDY ENTITLED, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL OF DEFERASIROX IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES (LOW/INT-1 RISK) & TRANSFUSIONAL IRON OVERLOAD
Regulatory Exclusivity Expiration:	Jul 23, 2023
Regulatory Exclusivity Use:	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	180MG
Approval Date:	May 18, 2017	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 24, 2022
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING FOR SAFETY & EFFICACY STUDY ENTITLED, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL OF DEFERASIROX IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES (LOW/INT-1 RISK) & TRANSFUSIONAL IRON OVERLOAD

Expired US Patents for NDA 207968

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017	⤷ Try a Trial	⤷ Try a Trial
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017	⤷ Try a Trial	⤷ Try a Trial
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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