← FDA DRUG APPROVALS

FDA BLA · BLA103948

CAMPATH

alemtuzumab

Sponsor: GENZYME

APPLICATION
BLA103948
TYPE
BLA
ORIGINAL APPROVAL
2001-05-07
LATEST ACTION
2024-05-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE, VIAL
MARKETING STATUS
Prescription

Products

LEMTRADAPrescription
ALEMTUZUMAB 12MG/1.2ML (10MG/ML) · INJECTABLE · INJECTION
CAMPATHPrescription
ALEMTUZUMAB 10MG/ML · VIAL · INTRAVENOUS
CAMPATHPrescription
ALEMTUZUMAB 30MG/ML · VIAL · INTRAVENOUS

Approval history

2024-05-20Labeling · Supplement 5193 · standard — Letter ↗AP
2024-03-04REMS · Supplement 5191 — Letter ↗AP
2024-02-08Labeling · Supplement 5192 · standard — Letter ↗AP
2023-04-26Labeling · Supplement 5188 · standard — Label ↗AP
2022-09-27Labeling · Supplement 5187 · standard — Label ↗AP
2022-05-26Labeling · Supplement 5185 · standard — Letter ↗AP
2022-01-13Labeling · Supplement 5184 · standard — Label ↗AP
2021-08-18Labeling · Supplement 5183 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 5182 · standard — Letter ↗AP
2021-03-12REMS · Supplement 5180 — Letter ↗AP
2020-10-22Labeling · Supplement 5181 · standard — Letter ↗AP
2020-09-25Labeling · Supplement 5177 · standard — Letter ↗AP
2020-09-25Labeling · Supplement 5179 · standard — Letter ↗AP
2020-06-29Labeling · Supplement 5176 · standard — Label ↗AP
2020-05-27Labeling · Supplement 5173 · standard — Letter ↗AP
2019-11-26Labeling · Supplement 5171 · standard — Letter ↗AP
2019-10-29Labeling · Supplement 5169 · standard — Letter ↗AP
2019-10-29Labeling · Supplement 5170 · standard — Letter ↗AP
2019-07-31Labeling · Supplement 5172 · 901 required — Letter ↗AP
2019-04-23REMS · Supplement 5168 — Letter ↗AP
2019-01-16Labeling · Supplement 5163 · standard — Label ↗AP
2019-01-16Labeling · Supplement 5164 · standard — Label ↗AP
2018-11-29Labeling · Supplement 5167 · standard — Label ↗AP
2018-11-28Labeling · Supplement 5165 · standard — Label ↗AP
2018-11-28Efficacy · Supplement 5160 · standard — Label ↗AP
2017-12-13Labeling · Supplement 5159 · standard — Letter ↗AP
2017-10-05Labeling · Supplement 5157 · 901 required — Label ↗AP
2017-10-05Labeling · Supplement 5158 · standardAP
2016-04-05REMS · Supplement 5153AP
2015-09-18REMS · Supplement 5151 — Letter ↗AP
2014-11-14Efficacy · Supplement 5139 · standardAP
2014-09-05Labeling · Supplement 5150 · standardAP
2009-03-30Labeling · Supplement 5092 · standardAP
2007-09-19Efficacy · Supplement 5070 · priority — Letter ↗AP
2004-05-19Labeling · Supplement 5035 · standardAP
2001-05-07Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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