← FDA DRUG APPROVALS

FDA NDA · NDA202714

KYPROLIS

carfilzomib

Sponsor: ONYX PHARMS AMGEN

APPLICATION
NDA202714
TYPE
NDA
ORIGINAL APPROVAL
2012-07-20
LATEST ACTION
2025-05-22
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

KYPROLIS · ReferencePrescription
CARFILZOMIB 30MG/VIAL · POWDER · INTRAVENOUS
KYPROLIS · ReferencePrescription
CARFILZOMIB 10MG/VIAL · POWDER · INTRAVENOUS
KYPROLIS · ReferencePrescription
CARFILZOMIB 60MG/VIAL · POWDER · INTRAVENOUS

Approval history

2025-05-22Efficacy · Supplement 36 · priority — Letter ↗AP
2022-06-30Efficacy · Supplement 34 · standard — Letter ↗AP
2021-11-30Efficacy · Supplement 33 · standard — Label ↗AP
2021-03-09Labeling · Supplement 32 · standard — Letter ↗AP
2020-08-20Efficacy · Supplement 30 · standard — Label ↗AP
2020-05-07Labeling · Supplement 29 · standard — Label ↗AP
2019-10-04Labeling · Supplement 27 · standard — Label ↗AP
2019-02-28Labeling · Supplement 25 · standard — Letter ↗AP
2018-09-28Efficacy · Supplement 21 · priority — Letter ↗AP
2018-06-07Efficacy · Supplement 19 · standard — Label ↗AP
2018-01-17Efficacy · Supplement 17 · standard — Letter ↗AP
2017-05-25Labeling · Supplement 16 · standard — Label ↗AP
2016-11-21Manufacturing (CMC) · Supplement 14 · standardAP
2016-11-17Labeling · Supplement 15 · standard — Letter ↗AP
2016-08-04Labeling · Supplement 13 · standard — Letter ↗AP
2016-06-03Labeling · Supplement 12 · standard — Letter ↗AP
2016-05-23Labeling · Supplement 11 · standard — Label ↗AP
2016-01-21Efficacy · Supplement 10 · priority — Label ↗AP
2015-07-24Efficacy · Supplement 9 · priority — Label ↗AP
2015-04-24Manufacturing (CMC) · Supplement 7 · standardAP
2015-04-21Manufacturing (CMC) · Supplement 6 · standardAP
2015-03-27Labeling · Supplement 8 · standard — Label ↗AP
2014-11-03Manufacturing (CMC) · Supplement 5 · standardAP
2014-06-02Manufacturing (CMC) · Supplement 4 · standardAP
2014-01-31Manufacturing (CMC) · Supplement 3 · standardAP
2013-04-19Manufacturing (CMC) · Supplement 2 · standardAP
2013-02-21Manufacturing (CMC) · Supplement 1 · standardAP
2012-07-20Type 1 - New Molecular Entity · Original · standard — Review ↗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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