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CENTERFORDRUGEVALUATIONAND
RESEARCH
APPLICATIONNUMBER:
200603
PHARMACOLOGYREVIEW(S)
TertiaryPharmacology/ToxicologyReview
From:PaulC.Brown,Ph.D.,ODEAssociateDirectorforPharmacologyand
Toxicology,ONDIO
NDA:200603
Agencyreceiptdate:12/30/2009
Drug:Lurasidonehydrochloride
Applicant:SunovionPharmaceuticals(OriginallysubmittedbyDainippon
SumimotoPharmaAmerica,Inc.)
Indication:schizophrenia
ReviewingDivision:DivisionofPsychiatryProducts
Background:
Thepharm/toxreviewerandteamleaderconcludedthatthenonclinicaldata
supportapprovaloflurasidonefortheindicationlistedabove.
ReproductiveandDevelopmentalToxicity:
Reproductiveanddevelopmentaltoxicitystudiesinratsandrabbitsrevealedno
evidenceofteratogenicityorembryofetaltoxicity.Thehighdosesintheratand
rabbitembryofetaltoxicitystudieswere3and12times,respectively,the
maximumrecommendedhumandose(80mg)basedonabodysurfacearea
comparison.
Carcinogenicity:
Lurasidonewastestedin2yearratandmousecarcinogenicitystudies.These
studieswerereviewedbythedivisionandtheexecutivecarcinogenicity
assessmentcommittee.Thecommitteeconcludedthatthestudieswere
adequateandthattherewasadrug-relatedincreaseinmammarycarcinomasin
femaleratsatdosesof12mg/kgandhigherandadrug-relatedincreasein
mammarycarcinomasandadenoacanthomasandpituitaryparsdistalis
adenomasinfemalemice.Theapplicantalsoprovideddatafromvariousstudies
showingthatlurasidonesignificantlyincreasesprolactininseveraldifferent
speciesincludingratsandmice.
Conclusions:
Iagreewiththedivisionpharm/toxconclusionthatthisapplicationcanbe
approvedfromapharm/toxperspective.
ThedivisionrecommendsthatlurasidonebelabeledwithpregnancycategoryB.
Thisisjustifiedgiventhela
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