Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103948
Company: GENZYME
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 |
|---|---|---|---|---|---|
| 04/26/2023 | SUPPL-5188 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103948s5188lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103948Orig1s5188ltr.pdf | |
| 09/27/2022 | SUPPL-5187 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5187lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103948Orig1s5187ltr.pdf | |
| 05/26/2022 | SUPPL-5185 | Supplement |
Label (PDF)
Letter (PDF) |
Letter for LEMTRADA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5185lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103948Orig1s5185ltr.pdf |
| 01/13/2022 | SUPPL-5184 | Supplement |
Label (PDF)
Letter (PDF) |
Label and Medication Guide for LEMTRADA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103948Orig1s5184ltr.pdf |
| 08/18/2021 | SUPPL-5183 | Supplement |
Label (PDF)
Letter (PDF) |
Label for LEMTRADA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103948s5183lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103948Orig1s5183ltr.pdf |
| 04/28/2021 | SUPPL-5182 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103948s5182lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103948Orig1s5182ltr.pdf | |
| 10/22/2020 | SUPPL-5181 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5181lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103948Orig1s5181ltr.pdf | |
| 03/12/2021 | SUPPL-5180 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103948Orig1s5180ltr.pdf |
| 09/25/2020 | SUPPL-5179 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103948Orig1s5177, s5179ltr.pdf | |
| 09/25/2020 | SUPPL-5177 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103948Orig1s5177, s5179ltr.pdf | |
| 06/29/2020 | SUPPL-5176 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103948Orig1s5176ltr.pdf | |
| 05/27/2020 | SUPPL-5173 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5173lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103948Orig1s5173ltr.pdf | |
| 07/31/2019 | SUPPL-5172 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103948Orig1s5172ltr.pdf | |
| 11/26/2019 | SUPPL-5171 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5171lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103948Orig1s5171ltr.pdf | |
| 10/29/2019 | SUPPL-5170 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5169s5170lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103948Orig1s5169,s5170ltr.pdf | |
| 10/29/2019 | SUPPL-5169 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5169s5170lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103948Orig1s5169,s5170ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/26/2023 | SUPPL-5188 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103948s5188lbl.pdf | |
| 04/26/2023 | SUPPL-5188 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103948s5188lbl.pdf | |
| 09/27/2022 | SUPPL-5187 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5187lbl.pdf | |
| 05/26/2022 | SUPPL-5185 | Labeling-Package Insert | Label (PDF) | Letter for LEMTRADA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5185lbl.pdf |
| 01/13/2022 | SUPPL-5184 | Labeling-Medication Guide | Label (PDF) | Label and Medication Guide for LEMTRADA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5184lbl.pdf |
| 01/13/2022 | SUPPL-5184 | Labeling-Package Insert | Label (PDF) | Label and Medication Guide for LEMTRADA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5184lbl.pdf |
| 08/18/2021 | SUPPL-5183 | Labeling-Package Insert | Label (PDF) | Label for LEMTRADA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103948s5183lbl.pdf |
| 04/28/2021 | SUPPL-5182 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103948s5182lbl.pdf | |
| 04/28/2021 | SUPPL-5182 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103948s5182lbl.pdf | |
| 10/22/2020 | SUPPL-5181 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5181lbl.pdf | |
| 09/25/2020 | SUPPL-5179 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf | |
| 09/25/2020 | SUPPL-5177 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf | |
| 09/25/2020 | SUPPL-5177 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf | |
| 06/29/2020 | SUPPL-5176 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5176lbl.pdf | |
| 05/27/2020 | SUPPL-5173 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5173lbl.pdf | |
| 11/26/2019 | SUPPL-5171 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5171lbl.pdf | |
| 10/29/2019 | SUPPL-5170 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5169s5170lbl.pdf | |
| 10/29/2019 | SUPPL-5170 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5169s5170lbl.pdf | |
| 10/29/2019 | SUPPL-5169 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5169s5170lbl.pdf | |
| 10/29/2019 | SUPPL-5169 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5169s5170lbl.pdf | |
| 07/31/2019 | SUPPL-5172 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5172lbl.pdf | |
| 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-Medication Guide | 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 |
| 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-Medication Guide | Label (PDF) | Label for LEMTRADA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5160_5165lbl.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-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. |