BLA 125277

DYAX CORP.

FDA Drug Application

Application #125277

Documents

• Letter: 2009-12-08
• Letter: 2011-05-17
• Letter: 2011-09-13
• Letter: 2012-04-27
• Letter: 2013-04-16
• Letter: 2014-04-02
• Letter: 2014-09-10
• Label: 2014-04-01
• Medication Guide: 2009-12-02
• Label: 2009-12-02
• Label: 2014-09-09
• Review: 2010-02-14
• Summary Review: 2010-02-14
• Label: 2020-12-28
• Medication Guide: 2020-12-28
• Letter: 2020-12-29

Application Sponsors

BLA 125277

DYAX CORP.

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

10MG/ML

0

KALBITOR

ECALLANTIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2009-12-01	PRIORITY
LABELING; Labeling	SUPPL	32	AP	2011-04-05	STANDARD
LABELING; Labeling	SUPPL	37	AP	2011-08-17	STANDARD
LABELING; Labeling	SUPPL	50	AP	2012-04-24	STANDARD
LABELING; Labeling	SUPPL	65	AP	2013-04-10	STANDARD
EFFICACY; Efficacy	SUPPL	70	AP	2014-03-28	PRIORITY
LABELING; Labeling	SUPPL	71	AP	2014-09-08	STANDARD
LABELING; Labeling	SUPPL	81	AP	2020-12-28	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	32	Null	7
SUPPL	50	Null	7
SUPPL	71	Null	15
SUPPL	81	Orphan	5

CDER Filings

DYAX CORP.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125277
            [companyName] => DYAX CORP.
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2009\/125277MedGuide.pdf"]
            [products] => [{"drugName":"KALBITOR","activeIngredients":"ECALLANTIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/08\/2014","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125277s071lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2014","submission":"SUPPL-70","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125277s070lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125277lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/01\/2009","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125277lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/125277s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2009\\\/125277s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2009\\\/125277s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/08\/2014","submission":"SUPPL-71","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125277s071lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125277Orig1s071ltr.pdf\"}]","notes":">"},{"actionDate":"03\/28\/2014","submission":"SUPPL-70","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125277s070lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125277Orig1s70ltr.pdf\"}]","notes":">"},{"actionDate":"04\/10\/2013","submission":"SUPPL-65","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125277Orig1s065ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2012","submission":"SUPPL-50","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125277s0050ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/17\/2011","submission":"SUPPL-37","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125277s037ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/05\/2011","submission":"SUPPL-32","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125277s032ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2014-09-08
        )

)