An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 125277
Company: DYAX CORP.

Medication Guide

Summary Review

Products on BLA 125277

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KALBITOR	ECALLANTIDE	10MG/ML	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125277

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2009	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125277s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/2020	SUPPL-81	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125277Orig1s081ltr.pdf
09/08/2014	SUPPL-71	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s071ltr.pdf
03/28/2014	SUPPL-70	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s70ltr.pdf
04/10/2013	SUPPL-65	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125277Orig1s065ltr.pdf
04/24/2012	SUPPL-50	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125277s0050ltr.pdf
08/17/2011	SUPPL-37	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s037ltr.pdf
04/05/2011	SUPPL-32	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s032ltr.pdf

Labels for BLA 125277

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/2020	SUPPL-81	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf
09/08/2014	SUPPL-71	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf
03/28/2014	SUPPL-70	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s070lbl.pdf
12/01/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277lbl.pdf

Top