Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID11789724serious1Date Last Updated06/01/2016receiptdateformat102seriousnessdeath1companynumbUS-MYLANLABS-2015M1041688occurcountryUSduplicate1Date Received01/12/2015transmissiondate25/05/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Reaction

1)

reactionmeddraversionpt19.0ReactionCompleted suicideOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate03/11/2015drugenddateformat602drugenddate//2015

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA075945Brand NameAMNESTEEMGeneric NameISOTRETINOINManufacturersMylan Pharmaceuticals Inc.product_ndc0378-6611, 0378-6612, 0378-6614Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 404058, 404061, 404064spl_id47bb51b9-0613-4708-905f-e950dbfa5127spl_set_idb2cb63c9-f825-4991-9a2c-6260f1bbcc2cPackage NDC 0378-6611-85, 0378-6611-93, 0378-6612-85, 0378-6612-93, 0378-6614-85, 0378-6614- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 20151115

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2015M1041688

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use