← FDA DRUG APPROVALS

FDA BLA · BLA125118

ORENCIA

abatacept

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
BLA125118
TYPE
BLA
ORIGINAL APPROVAL
2005-12-23
LATEST ACTION
2024-05-29
ROUTE
INTRAVENOUS, SUBCUTANEOUS, IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ORENCIAPrescription
ABATACEPT 250MG · INJECTABLE · IV (INFUSION)

Approval history

2024-05-29Labeling · Supplement 255 · standard — Letter ↗AP
2024-01-19Labeling · Supplement 249 · standard — Letter ↗AP
2023-10-30Efficacy · Supplement 250 · standard — Label ↗AP
2022-04-13Labeling · Supplement 235 · standard — Letter ↗AP
2021-12-15Efficacy · Supplement 240 · priority — Label ↗AP
2020-06-17Labeling · Supplement 199 · standard — Label ↗AP
2020-06-17Labeling · Supplement 225 · standard — Label ↗AP
2020-06-17Labeling · Supplement 194 · standard — Label ↗AP
2019-03-21Labeling · Supplement 224 · standard — Label ↗AP
2017-06-30Efficacy · Supplement 209 · standard — Label ↗AP
2017-03-30Efficacy · Supplement 211 · priority — Label ↗AP
2016-06-07Efficacy · Supplement 200 · standardAP
2014-12-30Labeling · Supplement 179 · standard — Letter ↗AP
2013-12-20Efficacy · Supplement 171 · standard — Label ↗AP
2012-02-17Labeling · Supplement 138 · standard — Label ↗AP
2011-08-18Labeling · Supplement 131 · standardAP
2011-07-29Efficacy · Supplement 122 · standard — Review ↗AP
2011-06-23Manufacturing (CMC) · Supplement 107 — Review ↗AP
2009-08-25Efficacy · Supplement 86 · standard — Label ↗AP
2008-04-07Efficacy · Supplement 45 · standard — Pediatric Statistical Review ↗AP
2008-03-21Labeling · Supplement 59 · standardAP
2007-03-13Efficacy · Supplement 16 · standard — Label ↗AP
2006-12-12Labeling · Supplement 18 · standardAP
2005-12-23Type 1 - New Molecular Entity · Original · priority — 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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