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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021560
Company: NOVARTIS

Medication Guide

Summary Review

Products on NDA 021560

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZORTRESS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	AB	Yes	No
ZORTRESS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	AB	Yes	No
ZORTRESS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	AB	Yes	No
ZORTRESS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021560

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/20/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021560s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021560s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000_zortress_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2023	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021560s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021560Orig1s033ltr.pdf
02/28/2024	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021560s032lbl.pdf
04/13/2023	SUPPL-31	Manufacturing (CMC)-Facility	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021560Orig1s031ltr.pdf
08/10/2018	SUPPL-22	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021560Orig1s022ltr.pdf
01/12/2018	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf
01/12/2018	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021560Orig1s020ltr.pdf
10/12/2016	SUPPL-19	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021560s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021560Orig1s019ltr.pdf
11/05/2015	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021560Orig1s018ltr.pdf
03/01/2016	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/24/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/14/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/05/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
01/27/2015	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021560Orig1s011ltr.pdf
03/26/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/02/2012	SUPPL-9	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560s009ltr.pdf
10/02/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560Orig1s008ltr.pdf
04/26/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560Orig1s007ltr.pdf
02/15/2013	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021560s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021560Orig1s006ltr.pdf
11/21/2011	SUPPL-4	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021560s004ltr.pdf

Labels for NDA 021560

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021560s032lbl.pdf
09/14/2023	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021560s033lbl.pdf
08/10/2018	SUPPL-22	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560Orig1s022lbl.pdf
01/12/2018	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf
01/12/2018	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf
01/12/2018	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s020lbl.pdf
10/12/2016	SUPPL-19	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021560s019lbl.pdf
11/05/2015	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s018lbl.pdf
01/27/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s011lbl.pdf
02/15/2013	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021560s006lbl.pdf
10/02/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s008lbl.pdf
04/26/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s007lbl.pdf
04/20/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021560s000lbl.pdf

Therapeutic Equivalents for NDA 021560

ZORTRESS

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	214138	ALKEM LABS LTD
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	205775	PAR PHARM
ZORTRESS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	214138	ALKEM LABS LTD
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	205775	PAR PHARM
ZORTRESS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

TABLET;ORAL; 0.75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	214138	ALKEM LABS LTD
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	205775	PAR PHARM
ZORTRESS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	214138	ALKEM LABS LTD
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	205775	PAR PHARM
ZORTRESS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

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