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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201532
Company: EISAI INC

Summary Review

Products on NDA 201532

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALAVEN	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201532

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2010	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/201532s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532s000_halaven_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/13/2022	SUPPL-23	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201532s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201532Orig1s023ltr.pdf
09/30/2021	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201532Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201532Orig1s021ltr.pdf
02/19/2021	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201532Orig1s020ltr.pdf
07/21/2016	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/19/2016	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201532Orig1s016ltr.pdf
01/28/2016	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201532Orig1s015ltr.pdf
11/18/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/27/2015	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201532s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201532s013ltr.pdf
04/10/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/19/2014	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201532Orig1s010ltr.pdf
08/01/2014	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201532Orig1s009ltr.pdf
10/24/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/27/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/22/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201532s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201532Orig1s006ltr.pdf
11/07/2012	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/17/2012	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201532s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201532s004ltr.pdf

Labels for NDA 201532

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/13/2022	SUPPL-23	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201532s023lbl.pdf
09/30/2021	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201532Orig1s021lbl.pdf
10/19/2016	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf
01/28/2016	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s015lbl.pdf
10/27/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201532s013lbl.pdf
12/19/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s010lbl.pdf
08/01/2014	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s009lbl.pdf
08/22/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201532s006lbl.pdf
02/17/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201532s004lbl.pdf
11/15/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf

Therapeutic Equivalents for NDA 201532

HALAVEN

SOLUTION;INTRAVENOUS; 1MG/2ML (0.5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218047	GLAND PHARMA LTD
HALAVEN	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201532	EISAI INC

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