omacetaxine mepesuccinate Injectable Solution

Brand(s)
Synribo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cephalon, Incorporated (2015-11-20)
Oldest Current Product
2012-11-19
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\OMACETAXINE MEPESUCCINATE
FDAOB
SUBCUTANEOUS\POWDER\OMACETAXINE MEPESUCCINATE
SPL Active
SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\OMACETAXINE MEPESUCCINATE
SPL Moiety
SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\OMACETAXINE

product(s) by strength(s)

omacetaxine mepesuccinate 3.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590177SynriboNDACephalon, Incorporated2012-11-19OMACETAXINE MEPESUCCINATESUBCUTANEOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA20358583a504ef-cf92-467d-9ecf-d251194a3484

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203585SYNRIBOIVAX INTERNATIONAL GMBH2012-10-26pRE45128, TREATMENT OF LEUKEMIA, SUBSTANCE
p6987103, TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)
ORPHAN DRUG EXCLUSIVITY [2019-10-26]
NEW CHEMICAL ENTITY [2017-10-26]
NDA203585_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203585_001RXOMACETAXINE MEPESUCCINATE (3.5MG/VIAL)SUBCUTANEOUSPOWDERTrue2012-10-26SYNRIBO

patent(s)

#idexpiration dateapplication(s)
1p6987103 (view patent)2023-06-28NDA203585
2pRE45128 (view patent)2019-03-16NDA203585

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
183a504ef-cf92-467d-9ecf-d251194a3484 (view SPL)These highlights do not include all the information needed to use SYNRIBO safely and effectively. See full prescribing information for SYNRIBO. SYNRIBO (omacetaxine mepesuccinate) for injection, for subcutaneous use Initial U.S. Approval: 2012prescriptionHuman PrescriptionCephalon, Incorporated2015-11-204634590177

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