Drugs@FDA: FDA-Approved Drugs

Biologic License Application (BLA): 103948
Company: GENZYME

Medication Guide

Other Important Information from FDA

REMS

Products on BLA 103948

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAMPATH	ALEMTUZUMAB	10MG/ML	VIAL; INTRAVENOUS	Prescription	None	No	No
CAMPATH	ALEMTUZUMAB	30MG/ML	VIAL; INTRAVENOUS	Prescription	None	No	No
LEMTRADA	ALEMTUZUMAB	12MG/1.2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Showing 1 to 3 of 3 entries

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103948

Original Approvals or Tentative Approvals

CSV Excel Print

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
05/07/2001	ORIG-1	Approval		N/A; Orphan	Label Letter Review

Showing 1 to 1 of 1 entries

Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/20/2024	SUPPL-5193	Supplement	Label (PDF) Letter (PDF)
03/04/2024	SUPPL-5191	Supplement	Letter (PDF)	Label is not available on this site.
02/08/2024	SUPPL-5192	Supplement	Label (PDF) Letter (PDF)
04/26/2023	SUPPL-5188	Supplement	Label (PDF) Letter (PDF)
09/27/2022	SUPPL-5187	Supplement	Label (PDF) Letter (PDF)
05/26/2022	SUPPL-5185	Supplement	Label (PDF) Letter (PDF)	Letter for LEMTRADA
01/13/2022	SUPPL-5184	Supplement	Label (PDF) Letter (PDF)	Label and Medication Guide for LEMTRADA
08/18/2021	SUPPL-5183	Supplement	Label (PDF) Letter (PDF)	Label for LEMTRADA
04/28/2021	SUPPL-5182	Supplement	Label (PDF) Letter (PDF)
03/12/2021	SUPPL-5180	Supplement	Letter (PDF)	Label is not available on this site.
10/22/2020	SUPPL-5181	Supplement	Label (PDF) Letter (PDF)
09/25/2020	SUPPL-5179	Supplement	Label (PDF) Letter (PDF)
09/25/2020	SUPPL-5177	Supplement	Label (PDF) Letter (PDF)
06/29/2020	SUPPL-5176	Supplement	Label (PDF) Letter (PDF)
05/27/2020	SUPPL-5173	Supplement	Label (PDF) Letter (PDF)
11/26/2019	SUPPL-5171	Supplement	Label (PDF) Letter (PDF)
10/29/2019	SUPPL-5170	Supplement	Label (PDF) Letter (PDF)
10/29/2019	SUPPL-5169	Supplement	Label (PDF) Letter (PDF)
07/31/2019	SUPPL-5172	Supplement	Label (PDF) Letter (PDF)
04/23/2019	SUPPL-5168	Supplement	Letter (PDF)	Label is not available on this site.
01/16/2019	SUPPL-5164	Supplement	Label (PDF) Letter (PDF)	Label for LEMTRADA
01/16/2019	SUPPL-5163	Supplement	Label (PDF)	Label for LEMTRADA
11/29/2018	SUPPL-5167	Supplement	Label (PDF) Letter (PDF)	Label for CAMPATH
11/28/2018	SUPPL-5165	Supplement	Label (PDF) Letter (PDF)	Label for LEMTRADA
11/28/2018	SUPPL-5160	Supplement	Label (PDF) Letter (PDF)	Label for LEMTRADA
12/13/2017	SUPPL-5159	Supplement	Label (PDF) Letter (PDF)	Label for LEMTRADA
10/05/2017	SUPPL-5158	Supplement		Label is not available on this site.
10/05/2017	SUPPL-5157	Supplement	Label (PDF)	Label for CAMPATH
04/05/2016	SUPPL-5153	Supplement		Label is not available on this site.
09/18/2015	SUPPL-5151	Supplement	Letter (PDF) Review (PDF)	Label is not available on this site.
11/14/2014	SUPPL-5139	Supplement		Label is not available on this site.
09/05/2014	SUPPL-5150	Supplement		Label is not available on this site.
03/30/2009	SUPPL-5092	Supplement		Label is not available on this site.
09/19/2007	SUPPL-5070	Supplement	Letter (PDF)	Label is not available on this site.
05/19/2004	SUPPL-5035	Supplement		Label is not available on this site.

Showing 1 to 35 of 35 entries

Labels for BLA 103948

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/20/2024	SUPPL-5193	Labeling-Package Insert	Label (PDF)
02/08/2024	SUPPL-5192	Labeling-Package Insert	Label (PDF)
04/26/2023	SUPPL-5188	Labeling-Package Insert	Label (PDF)
04/26/2023	SUPPL-5188	Labeling-Patient Package Insert	Label (PDF)
09/27/2022	SUPPL-5187	Labeling-Package Insert	Label (PDF)
05/26/2022	SUPPL-5185	Labeling-Package Insert	Label (PDF)	Letter for LEMTRADA
01/13/2022	SUPPL-5184	Labeling-Medication Guide	Label (PDF)	Label and Medication Guide for LEMTRADA
01/13/2022	SUPPL-5184	Labeling-Package Insert	Label (PDF)	Label and Medication Guide for LEMTRADA
08/18/2021	SUPPL-5183	Labeling-Package Insert	Label (PDF)	Label for LEMTRADA
04/28/2021	SUPPL-5182	Labeling-Medication Guide	Label (PDF)
04/28/2021	SUPPL-5182	Labeling-Package Insert	Label (PDF)
10/22/2020	SUPPL-5181	Labeling-Package Insert	Label (PDF)
09/25/2020	SUPPL-5179	Labeling-Package Insert	Label (PDF)
09/25/2020	SUPPL-5177	Labeling-Package Insert	Label (PDF)
09/25/2020	SUPPL-5177	Labeling-Medication Guide	Label (PDF)
06/29/2020	SUPPL-5176	Labeling-Package Insert	Label (PDF)
05/27/2020	SUPPL-5173	Labeling-Package Insert	Label (PDF)
11/26/2019	SUPPL-5171	Labeling-Package Insert	Label (PDF)
10/29/2019	SUPPL-5170	Labeling-Package Insert	Label (PDF)
10/29/2019	SUPPL-5170	Labeling-Medication Guide	Label (PDF)
10/29/2019	SUPPL-5169	Labeling-Package Insert	Label (PDF)
10/29/2019	SUPPL-5169	Labeling-Medication Guide	Label (PDF)
07/31/2019	SUPPL-5172	Labeling-Package Insert	Label (PDF)
01/16/2019	SUPPL-5164	Labeling-Medication Guide	Label (PDF)	Label for LEMTRADA
01/16/2019	SUPPL-5164	Labeling-Package Insert	Label (PDF)	Label for LEMTRADA
01/16/2019	SUPPL-5163	Labeling-Medication Guide	Label (PDF)	Label for LEMTRADA
01/16/2019	SUPPL-5163	Labeling-Package Insert	Label (PDF)	Label for LEMTRADA
11/29/2018	SUPPL-5167	Labeling-Medication Guide	Label (PDF)	Label for CAMPATH
11/29/2018	SUPPL-5167	Labeling-Package Insert	Label (PDF)	Label for CAMPATH
11/28/2018	SUPPL-5165	Labeling-Package Insert	Label (PDF)	Label for LEMTRADA
11/28/2018	SUPPL-5165	Labeling-Medication Guide	Label (PDF)	Label for LEMTRADA
11/28/2018	SUPPL-5160	Efficacy-Labeling Change With Clinical Data	Label (PDF)	Label for LEMTRADA
12/13/2017	SUPPL-5159	Labeling-Package Insert	Label (PDF)	Label for LEMTRADA
10/05/2017	SUPPL-5157	Labeling-Package Insert	Label (PDF)	Label for CAMPATH
05/07/2001	ORIG-1	Approval

Showing 1 to 35 of 35 entries