Adverse Event Report

Report

reporttype2receiptdateformat102companynumbUS-MYLANLABS-2014M1008372occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10865389Date Received24/02/2015transmissiondate21/07/2015serious2Date Last Updated24/02/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age20Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionStressOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionAcneOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionPain of skinOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, BIDdrugdosageformCAPSULEdrugadministrationroute048drugindicationACNE CYSTICdrugstartdateformat102drugstartdate17/09/2014drugenddateformat102drugenddate09/10/2014actiondrug1

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

2)

drugcharacterization1medicinalproductMYORISANdrugdosagetextUNKdrugindicationACNE CYSTICactiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076485Brand NameMYORISANGeneric NameISOTRETINOINManufacturersVersapharm Incorporatedproduct_ndc61748-301, 61748-302, 61748-303, 61748-304Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1242611, 1242613, 1242615, 1663728spl_id703dd363-236a-4a17-85e9-feb1b3ae540bspl_set_id51ff6346-9256-4c01-9f52-417d13f2df05Package NDC 61748-301-13, 61748-301-11, 61748-301-01, 61748-302-13, 61748-302-11, 61748-302- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 20140917

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014M1008372