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Organic chemistry / Medicine / Fluoxetine / Antidepressant / Paroxetine / Investigational New Drug / Food and Drug Administration / Desvenlafaxine / Escitalopram / Chemistry / Selective serotonin reuptake inhibitors / Organofluorides


Pediatric Program Summary Statistics Since the pediatric exclusivity program began, 283 Written Requests have been issued and 88 drugs have been granted exclusivity. Among these, only fluoxetine has been approved for the
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Document Date: 2004-01-13 09:43:14


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City

Rockville / /

IndustryTerm

drug product / treatment of major depressive disorder / /

MedicalCondition

same disease / adult and pediatric depression / major depressive disorder / disease / disorder / adult depression / depression / pediatric depression / pediatric major depressive disorder / /

Organization

Division of Neuropharmacologic Drug Products / Center for Drug Evaluation and Research / office of Generic Drugs / Food and Drug Administration / Director Office / /

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Position

messenger / Regulatory Project Manager / Director / /

Product

fluoxetine / Insert Drug / /

ProvinceOrState

Maryland / /

Technology

pharmacokinetics / CGI / /

URL

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

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