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Medicine / Chemistry / Pharmacology / Treatment of bipolar disorder / Epilepsy / Valproate semisodium / Adverse Event Reporting System / Lamotrigine / Valproic acid / Anticonvulsants / Mood stabilizers / Teratogens


Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Date:
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Company

Abbott Laboratories / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

year age / Treatment of Bipolar Disorder / treatment for bipolar disorder / treatment of migraine / biopharmaceutical / treatment of pediatric bipolar disorder / literature search / /

MedicalCondition

partial seizures / Absence Seizures / Grand Mal Convulsion / neutropenia described improved neutrophil counts / Myoclonus / urea cycle disorders / hyperammonemia/encephalopathy / thrombocytopenia / complex absence seizures / Event Cases Mentioning Pancreatitis / Infantile Spasms / Intermittent Explosive Disorder / Stevens-Johnson Syndrome / complex partial seizures / polystic ovary disease / I diabetes mellitus / multi-organ hypersensitivity / hepatitis / I Diabetes / pediatric bipolar disorder / parkinsonism / Personality Disorder / adolescent mania / hyperglycemia / pediatric epilepsy / hypothermia / autism / Adverse Event Cases Mentioning Stevens-Johnson Syndrome / migraine / mania / Asperger's Disorder / seizure / Petit Mal Epilepsy / migraine headaches / hyperandrogenism / Affective Disorder / ovarian cysts / hepatic failure / valproic acid-associated pancreatitis / pancreatitis / Mood Disorder / epilepsy / hemorrhagic pancreatitis / Depression / simple and complex absence seizures / rash / Febrile Convulsion / bipolar disorder / pancytopenia / /

MedicalTreatment

concomitant therapy / adjunctive therapy / /

OperatingSystem

OSE / /

Organization

office of New Drugs / office of Surveillance and Epidemiology / office of Pediatric Therapeutics / Research office of Surveillance and Epidemiology Date / Director office of Pediatric Therapeutics / Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation / FDA / /

Person

Lisa L. Mathis / Mark Avigan / Cindy Kortepeter / M. Dianne Murphy / Joseph M. Tonning / Ni Khin / /

/

Position

Team Leader / Director Division of Pharmacovigilance / contractor / Associate Director / EXECUTIVE / CONTENTS EXECUTIVE / Director Pediatric and Maternal Health Staff / /

Product

Depakote ER / Divalproex sodium / Divalproex / Sprinkle Capsules / lamotrigine / gabapentin / valproic acid / Depakote CP / Depakote / Depakote® NDAs / BACKGROUND Depakote ER® (divalproex sodium) / OSE/DPV I Subject / Depakote ER® / Depakote ER (divalproex sodium) extended release tablets / /

Technology

pdf / http / /

URL

http /

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