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Pharmacology / Organofluorides / Eli Lilly and Company / Serotonin-norepinephrine reuptake inhibitors / Duloxetine / Paroxetine / Antidepressant / Fluoxetine / Clinical trial / Chemistry / Organic chemistry / Selective serotonin reuptake inhibitors


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City

Rockville / /

Company

M.D. / GI-1 ELI LILLY AND CO / Eli Lilly & Company / Elite Pharmaceuticals Inc. / /

Event

Product Issues / FDA Phase / Product Recall / /

Facility

Robert Temple / U.S. Regulatory Affairs Lilly Corporate Center / /

IndustryTerm

treatment of pediatric major depressive disorder / /

MedicalCondition

adult major depressive disorder / major depressive disorder / disease / Pediatric Major Depressive Disorder / hepatic injury / same disease / dyskinesias / disorder / depression / pediatric depression / /

Organization

Food and Drug Administration / U.S. Regulatory Affairs Lilly Corporate Center Indianapolis / Center for Drug Evaluation and Research Application Type/Number / office of Generic Drugs / DEPARTMENT OF HEALTH / /

Person

Bryan Boggs / Renmeet Grewal / /

/

Position

Governor / PEDIATRIC MDD General / Senior Regulatory Project Manager / Manager / Director / Major / child psychiatrist / Director Office / licensed pharmacist / messenger / /

Product

fluoxetine / Cymbalta / trial / developing / GI-1 / /

ProvinceOrState

Alaska / Maryland / Indiana / /

Technology

alpha / pharmacokinetics / Entry Criteria The protocols / CGI / /

URL

www.fda.gov/cder/guidance/index.htm / www.fda.gov/cder/guidance/1852fnl.pdf / www.ClinicalTrials.gov / /

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