tesamorelin Injection

Brand(s)
Egrifta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Theratechnologies Inc. (2015-06-23)
Oldest Current Product
2014-07-14
License(s)
NDA
RxNORM
INJECTION\TESAMORELIN
FDAOB
SUBCUTANEOUS\POWDER\TESAMORELIN ACETATE

product(s) by strength(s)

tesamorelin 2 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1620640011EgriftaNDATheratechnologies Inc.2014-07-14TESAMORELIN ACETATEKITNDA02250567d362c1-078c-11e4-9191-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022505EGRIFTATHERATECHNOLOGIES INC2010-11-10p5861379, REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY, SUBSTANCE
p7316997, REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY
p6020311, REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY, SUBSTANCE
p7144577, REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY
NEW CHEMICAL ENTITY [2015-11-10]NDA022505_001, NDA022505_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022505_001RXTESAMORELIN ACETATE (EQ 1MG BASE/VIAL)SUBCUTANEOUSPOWDERTrue2010-11-10EGRIFTA
2NDA022505_002discontinuedTESAMORELIN ACETATE (EQ 2MG BASE/VIAL)SUBCUTANEOUSPOWDERFalse2011-11-29EGRIFTA

patent(s)

#idexpiration dateapplication(s)
1p5861379 (view patent)2020-05-26NDA022505
2p6020311 (view patent)2015-05-26NDA022505
3p7144577 (view patent)2020-07-14NDA022505
4p7316997 (view patent)2023-08-14NDA022505

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
13de31cec-31dc-4ac4-9717-367a687d22f2 (view SPL)These highlights do not include all the information needed to use EGRIFTA safely and effectively. See full prescribing information for EGRIFTA. EGRIFTA (tesamorelin for injection), for subcutaneous useInitial U.S. Approval: 2010prescriptionHuman PrescriptionEmd Serono, Inc.2013-02-214440872011
267d362c1-078c-11e4-9191-0800200c9a66 (view SPL)These highlights do not include all the information needed to use EGRIFTA safely and effectively. See full prescribing information for EGRIFTA.EGRIFTA (tesamorelin for injection), for subcutaneous useInitial U.S. Approval: 2010prescriptionHuman PrescriptionTheratechnologies Inc.2015-06-233620640011

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