← FDA DRUG APPROVALS

FDA BLA · BLA125085

AVASTIN

bevacizumab

Sponsor: GENENTECH

APPLICATION
BLA125085
TYPE
BLA
ORIGINAL APPROVAL
2004-02-26
LATEST ACTION
2022-09-18
ROUTE
INTRAVENOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

AVASTINPrescription
BEVACIZUMAB 100MG · VIAL · INTRAVENOUS
AVASTINPrescription
BEVACIZUMAB 400MG · VIAL · INTRAVENOUS

Approval history

2022-09-18Labeling · Supplement 340 · standard — Letter ↗AP
2020-12-09Labeling · Supplement 337 · standard — Label ↗AP
2020-10-09Labeling · Supplement 336 · standard — Letter ↗AP
2020-09-30Labeling · Supplement 334 · standard — Letter ↗AP
2020-05-29Efficacy · Supplement 332 · priority — Label ↗AP
2019-06-20Labeling · Supplement 331 · standard — Label ↗AP
2019-04-03Manufacturing (CMC) · Supplement 329 — Letter ↗AP
2018-06-13Efficacy · Supplement 323 · standard — Label ↗AP
2018-04-30Efficacy · Supplement 324 · standard — Label ↗AP
2017-12-05Efficacy · Supplement 319 · standard — Letter ↗AP
2016-12-06Efficacy · Supplement 317 · priority — Label ↗AP
2015-12-01Labeling · Supplement 312 · standard — Letter ↗AP
2015-09-29Labeling · Supplement 310 · standard — Label ↗AP
2015-05-07Labeling · Supplement 308 · standard — Label ↗AP
2014-11-14Efficacy · Supplement 305 · priority — Letter ↗AP
2014-08-30Labeling · Supplement 297 · standard — Label ↗AP
2014-08-14Efficacy · Supplement 301 · priority — Summary Review ↗AP
2013-12-16Labeling · Supplement 285 · standard — Label ↗AP
2013-03-26Labeling · Supplement 267 · standard — Label ↗AP
2013-01-23Efficacy · Supplement 263 · priority — Label ↗AP
2012-11-20Labeling · Supplement 265 · standard — Letter ↗AP
2012-10-26Efficacy · Supplement 239 · standard — Label ↗AP
2012-05-03Labeling · Supplement 238 · standard — Letter ↗AP
2011-12-21Labeling · Supplement 229 · standardAP
2011-12-21Labeling · Supplement 235 · standardAP
2011-12-20Labeling · Supplement 241 · standard — Letter ↗AP
2011-09-30Labeling · Supplement 225 · standard — Letter ↗AP
2011-02-08Labeling · Supplement 208 · standard — Letter ↗AP
2010-12-28Labeling · Supplement 204 · standard — Letter ↗AP
2009-07-31Efficacy · Supplement 168 · standard — Label ↗AP
2009-05-05Efficacy · Supplement 169 · priority — Label ↗AP
2008-11-04Labeling · Supplement 163 · standardAP
2008-03-10Labeling · Supplement 145 · standard — Label ↗AP
2008-02-22Efficacy · Supplement 91 · priority — Letter ↗AP
2007-09-20Labeling · Supplement 131 · standard — Label ↗AP
2006-10-11Efficacy · Supplement 85 · priority — Label ↗AP
2006-09-21Labeling · Supplement 82 · standard — Label ↗AP
2006-06-20Efficacy · Supplement 74 · priority — Review ↗AP
2006-04-18Labeling · Supplement 67 · standard — Label ↗AP
2005-09-29Efficacy · Supplement 45 · standard — Label ↗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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