Details for New Drug Application (NDA): 021882

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NDA 021882 describes EXJADE, 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 EXJADE profile page.

The generic ingredient in EXJADE 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 021882

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

Pharmacology for NDA: 021882

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

Suppliers and Packaging for NDA: 021882

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882	NDA	Novartis Pharmaceuticals Corporation	0078-0468	0078-0468-15	30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)
EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882	NDA	Novartis Pharmaceuticals Corporation	0078-0469	0078-0469-15	30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0469-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	125MG
Approval Date:	Nov 2, 2005	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:	TABLET, FOR SUSPENSION;ORAL			Strength	250MG
Approval Date:	Nov 2, 2005	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 021882

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	⤷ Try a Trial	⤷ Try a Trial
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	⤷ Try a Trial	⤷ Try a Trial
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	⤷ Try a Trial	⤷ Try a Trial
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	⤷ Try a Trial	⤷ Try a Trial
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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