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Medicine / Off-label use / Food and Drug Administration / Adverse effect / Antipsychotic / Lurasidone / Pharmacology / Chemistry / Organic chemistry


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993
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City

Fort Lee / Beltsville / /

Company

Regulatory Affairs Sunovion Pharmaceuticals Inc. / RAC Sunovion Pharmaceuticals Inc. / Sunovion Pharmaceuticals Inc. / /

Event

FDA Phase / Product Issues / /

Facility

Inc. One Bridge Plaza / /

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IndustryTerm

hazardous machinery / treatment of bipolar disorder / healthcare professional / /

MedicalCondition

schizophrenia / parkinsonism / seizures / leukopenia / hyperglycemia / neutropenia / nausea / dyslipidemia / hypersomnia / syncope / orthostatic hypotension / diabetes mellitus / hypersensitivity / neuroleptic malignant syndrome / MS / tardive dyskinesia / hypersomnolence / agranulocytosis / bipolar disorder / hyperprolactinemia / akathisia / /

Organization

Division of Direct-toConsumer Promotion / Food and Drug Administration / Division of Professional Promotion / U.S. Food and Drug Administration / Division of Drug Marketing / Advertising / and Communications / office of Prescription Drug Promotion / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH / Professional Promotion Office / /

Person

Silver Spring / Unapproved Uses / JESSICA N CLECK DERENICK / Jessica N. Cleck Derenick / /

Position

psychiatrist / sales representative / Director / PhD Regulatory Review Officer Division / /

Product

Latuda / MA / LATUDA® (lurasidone HCl) Tablets / machinery / /

ProvinceOrState

New Jersey / Maryland / /

SocialTag