Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103948
Company: GENZYME
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/07/2001 ORIG-1 Approval N/A; Orphan Label
Letter
Review
https://web.archive.org/web/20170222172020/https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm088606. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/alemmil050701L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/103948s000_CampathTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/23/2019 SUPPL-5168 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103948Orig1s5168ltr.pdf
11/29/2018 SUPPL-5167 Supplement Label (PDF)
Letter (PDF)
Label for CAMPATH https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103948Orig1s5167ltr.pdf
11/28/2018 SUPPL-5165 Supplement Label (PDF)
Letter (PDF)
Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5160_5165lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103948Orig1s5160, s5165ltr.pdf
01/16/2019 SUPPL-5164 Supplement Label (PDF)
Letter (PDF)
Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103948s5163s5164ltr.pdf
01/16/2019 SUPPL-5163 Supplement Label (PDF)
Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf
11/28/2018 SUPPL-5160 Supplement Label (PDF)
Letter (PDF)
Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5160_5165lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103948Orig1s5160, s5165ltr.pdf
12/13/2017 SUPPL-5159 Supplement Label (PDF)
Letter (PDF)
Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103948s5159lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103948Orig1s5159ltr.pdf
10/05/2017 SUPPL-5158 Supplement

Label is not available on this site.

10/05/2017 SUPPL-5157 Supplement Label (PDF)
Label for CAMPATH https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103948s5157lbl.pdf
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.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103948Orig1s5151ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/103948Orig1s5151.pdf
09/05/2014 SUPPL-5150 Supplement

Label is not available on this site.

11/14/2014 SUPPL-5139 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.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103948s5070lt.pdf
05/19/2004 SUPPL-5035 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/16/2019 SUPPL-5164 Labeling-Medication Guide Label (PDF) Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf
01/16/2019 SUPPL-5164 Labeling-Package Insert Label (PDF) Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf
01/16/2019 SUPPL-5163 Labeling-Package Insert Label (PDF) Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf
01/16/2019 SUPPL-5163 Labeling-Medication Guide Label (PDF) Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf
11/29/2018 SUPPL-5167 Labeling-Medication Guide Label (PDF) Label for CAMPATH https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5167lbl.pdf
11/29/2018 SUPPL-5167 Labeling-Package Insert Label (PDF) Label for CAMPATH https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5167lbl.pdf
11/28/2018 SUPPL-5165 Labeling-Package Insert Label (PDF) Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5160_5165lbl.pdf
11/28/2018 SUPPL-5165 Labeling-Medication Guide Label (PDF) Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5160_5165lbl.pdf
11/28/2018 SUPPL-5160 Efficacy-Labeling Change With Clinical Data Label (PDF) Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5160_5165lbl.pdf
12/13/2017 SUPPL-5159 Labeling-Package Insert Label (PDF) Label for LEMTRADA https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103948s5159lbl.pdf
10/05/2017 SUPPL-5157 Labeling-Package Insert Label (PDF) Label for CAMPATH https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103948s5157lbl.pdf
05/07/2001 ORIG-1 Approval https://web.archive.org/web/20170222172020/https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm088606.

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