icatibant Prefilled Syringe

Brand(s)
Firazyr
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shire (2015-08-14)
Oldest Current Product
2011-08-25
License(s)
NDA
RxNORM
PREFILLED SYRINGE\ICATIBANT
FDAOB
SUBCUTANEOUS\INJECTION\ICATIBANT ACETATE
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\ICATIBANT ACETATE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\ICATIBANT

product(s) by strength(s)

3 ml icatibant 10 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1540920702FirazyrNDAShire2011-08-25ICATIBANT ACETATESUBCUTANEOUSINJECTION, SOLUTIONNDA022150ed6657ca-ab68-477a-9968-e12dc928b540

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022150FIRAZYRSHIRE ORPHAN THERAPIES INC2011-08-25p5648333, TREATMENT OF PATHOLOGICAL STATE BY ANTAGONIZING BRADYKININ RECEPTOR INCLUDING TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE), SUBSTANCEORPHAN DRUG EXCLUSIVITY [2018-08-25]
NEW CHEMICAL ENTITY [2016-08-25]
NDA022150_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022150_001RXICATIBANT ACETATE (EQ 30MG BASE/3ML)SUBCUTANEOUSINJECTIONTrue2011-08-25FIRAZYR

patent(s)

#idexpiration dateapplication(s)
1p5648333 (view patent)2019-07-15NDA022150

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1ed6657ca-ab68-477a-9968-e12dc928b540 (view SPL)These highlights do not include all the information needed to use FIRAZYR (icatibant) safely and effectively. See full prescribing information for FIRAZYR. FIRAZYR (icatibant) Injection, for subcutaneous use Initial U.S. Approval: 2011prescriptionHuman PrescriptionShire2015-08-149540920702

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII