Adverse Event Report

Report

reporttype2Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10070956serious1Date Last Updated04/11/2014receiptdateformat102companynumbUS-MYLANLABS-2014S1007758occurcountryUSseriousnessother1duplicate1Date Received10/04/2014transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age30Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAbortion inducedOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionExposure during pregnancyOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80 MG,QDdrugdosageformCAPSULEdrugstartdateformat102drugstartdate02/07/2013actiondrug1

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)

drugcharacterization1medicinalproductCLARAVISdrugdosagetextUNKdrugdosageformCAPSULEactiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076356, ANDA076135Brand NameCLARAVISGeneric NameISOTRETINOINManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-1054, 0555-1055, 0555-1056, 0555-1057Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488spl_ide462821c-84c4-4009-a26e-da92790126bfspl_set_ida31fd109-d0fd-4ab9-ba98-a3d64333c18dPackage NDC 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

3)

drugcharacterization1medicinalproductCLARAVISdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext30 MG,TIDdrugdosageformCAPSULEactiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076356, ANDA076135Brand NameCLARAVISGeneric NameISOTRETINOINManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-1054, 0555-1055, 0555-1056, 0555-1057Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488spl_ide462821c-84c4-4009-a26e-da92790126bfspl_set_ida31fd109-d0fd-4ab9-ba98-a3d64333c18dPackage NDC 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 20140321

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014S1007758

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use