← FDA DRUG APPROVALS

FDA BLA · BLA125277

KALBITOR

ecallantide

Sponsor: DYAX CORP.

APPLICATION
BLA125277
TYPE
BLA
ORIGINAL APPROVAL
2009-12-01
LATEST ACTION
2020-12-28
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

KALBITORPrescription
ECALLANTIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2020-12-28Labeling · Supplement 81 · standard — Label ↗AP
2014-09-08Labeling · Supplement 71 · standard — Label ↗AP
2014-03-28Efficacy · Supplement 70 · priority — Letter ↗AP
2013-04-10Labeling · Supplement 65 · standard — Letter ↗AP
2012-04-24Labeling · Supplement 50 · standard — Letter ↗AP
2011-08-17Labeling · Supplement 37 · standard — Letter ↗AP
2011-04-05Labeling · Supplement 32 · standard — Letter ↗AP
2009-12-01Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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