Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-009507513-1403USA008346occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10045627Date Received28/03/2014transmissiondate02/10/2014serious2Date Last Updated28/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age62Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDry skinOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionInjection site reactionOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionInjection site erythemaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionNauseaOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductPEGINTRONdrugauthorizationnumb103949drugstructuredosagenumb.4drugstructuredosageunit012drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext0.4 ML, QW, REDIPENdrugdosageformPOWDER FOR INJECTIONdrugadministrationroute058drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate07/03/2014actiondrug4

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Application NumberBLA103949Brand NamePEGINTRONGeneric NamePEGINTERFERON ALFA-2BManufacturersMerck Sharp & Dohme Corp.product_ndc 0085-1297, 0085-1323, 0085-1316, 0085-1370, 0085-4353, 0085-4354, 0085-4355, 008 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsPEGINTERFERON ALFA-2BRXCUI 284192, 284193, 284194, 284195, 731333, 731334, 731345, 731348, 760029, 760039, ... spl_id519a40d2-566f-4d64-8ffb-35813db6c6aespl_set_idb70816bb-913a-467f-acb8-67ef62cf8dacPackage NDC 0085-1323-01, 0085-1323-02, 0085-1316-01, 0085-1316-02, 0085-1297-03, 0085-1297- ... NUIN0000175521, M0025711Established Pharmacologic ClassInterferon alpha [EPC]Chemical StructureInterferon-alpha [CS]UNIIG8RGG88B68

2)

drugcharacterization1medicinalproductREBETOLdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, BIDdrugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate07/03/2014actiondrug4

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Application NumberNDA021546Brand NameREBETOLGeneric NameRIBAVIRINManufacturersMerck Sharp & Dohme Corp.product_ndc0085-1318, 0085-1351, 0085-1385, 0085-1194Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIBAVIRINRXCUI248112, 312817, 352007, 544400spl_idc1e62cfb-c88b-4f4a-bfc0-351c71f64062spl_set_id04d2b6f4-bd9b-4871-9527-92c81aa2d4d0Package NDC0085-1351-05, 0085-1385-07, 0085-1194-03, 0085-1318-01NUIN0000175459, N0000175466Established Pharmacologic ClassNucleoside Analog Antiviral [EPC]UNII49717AWG6K

3)

drugcharacterization2medicinalproductSOVALDIdrugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400 MG, QDdrugadministrationroute048drugrecurreadministration3

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Application NumberNDA204671, NDA212480Brand NameSOVALDIGeneric NameSOFOSBUVIRManufacturersGilead Sciences, Inc.product_ndc61958-1501, 61958-1503, 61958-1504, 61958-1505Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOFOSBUVIRRXCUI1484916, 1484922, 2203891, 2203893, 2203993, 2203999, 2204090, 2204092spl_idb6ff385d-224a-0bad-e053-2995a90adcd4spl_set_id80beab2c-396e-4a37-a4dc-40fdb62859cfPackage NDC61958-1501-1, 61958-1503-1, 61958-1504-1, 61958-1505-1NUIN0000191493, N0000191258, N0000175459Established Pharmacologic ClassHepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]Mechanism of ActionRNA Replicase Inhibitors [MoA]UNIIWJ6CA3ZU8B

4)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, QDdrugrecurreadministration3

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Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

5)

drugcharacterization2medicinalproductWELLBUTRINdrugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MG, QDdrugrecurreadministration3

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Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_ida4bd6e04-f597-4ad4-966d-86cf2efbf5fa, ed416049-f26b-453e-b89a-10bdf7091734spl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

6)

drugcharacterization2medicinalproductMYSOLINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, TIDdrugrecurreadministration3

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Application NumberNDA009170Brand NameMYSOLINEGeneric NamePRIMIDONEManufacturersBausch Health US, LLCproduct_ndc66490-690, 66490-691Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRIMIDONERXCUI96304, 198150, 201747, 207478spl_id9d9f03b1-4eb4-4ba5-a357-600e368802c6spl_set_idaf593171-dabb-4ea3-b44c-89ed457b2c46Package NDC66490-690-10, 66490-691-10NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII13AFD7670Q

7)

drugcharacterization2medicinalproductNORVASCdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDdrugrecurreadministration3

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Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id3f5ca9a3-9076-49ab-b247-669c337f3364spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

8)

drugcharacterization2medicinalproductBETAPACEdrugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80 MG, BIDdrugrecurreadministration3

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Application NumberNDA019865Brand NameBETAPACEGeneric NameSOTALOL HYDROCHLORIDEManufacturersCovis Pharmaproduct_ndc70515-105, 70515-109, 70515-106, 70515-115, 70515-119, 70515-116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOTALOL HYDROCHLORIDERXCUI 1922720, 1922721, 1922763, 1922764, 1922765, 1922766, 1923422, 1923423, 1923424, ... spl_idc70abe53-97e1-4f5e-8e76-d207e1f87fe2spl_set_idafce2787-8899-4098-87c8-f1e8dd19e6ddPackage NDC 70515-105-10, 70515-109-10, 70515-106-10, 70515-115-06, 70515-119-06, 70515-116- ... UNIIHEC37C70XX

9)

drugcharacterization2medicinalproductCOUMADINdrugdosagetext1 DAILY EXCEPT WEDNESDAYdrugrecurreadministration3

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10)

drugcharacterization2medicinalproductCOUMADINdrugdosagetext1/2 TAB ON WEDNESDAYdrugrecurreadministration3

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11)

drugcharacterization2medicinalproductPLAVIXdrugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MG, QDdrugrecurreadministration3

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Application NumberNDA020839Brand NamePLAVIXGeneric NameCLOPIDOGRELManufacturerssanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnershipproduct_ndc0024-1171, 0024-1332, 63653-1171, 63653-1332Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI213169, 309362, 749196, 749198spl_idcb770afe-b6de-469f-9d9c-3db134394d4d, 12eb3088-f30b-4bb5-aee0-113114b5a08cspl_set_idde8b0b67-eb25-4684-83b5-7ad785314227, 01b14603-8f29-4fa3-8d7e-9d523f802e0bPackage NDC 0024-1171-90, 0024-1332-30, 63653-1171-6, 63653-1171-1, 63653-1171-3, 63653-1171 ... UNII08I79HTP27

12)

drugcharacterization2medicinalproductHYZAARdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, QDdrugrecurreadministration3

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Application NumberNDA020387Brand NameHYZAARGeneric NameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0717, 0006-0745, 0006-0747Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDERXCUI979464, 979466, 979468, 979470, 979471, 979473spl_id32622632-0367-4cc0-ae2e-21b02371dfcbspl_set_idd3e434b9-2f56-4dec-8cbf-a61e23abcc6aPackage NDC 0006-0717-31, 0006-0717-54, 0006-0717-82, 0006-0745-31, 0006-0745-54, 0006-0745- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII3ST302B24A, 0J48LPH2TH

13)

drugcharacterization2medicinalproductDILTIAZEM HYDROCHLORIDEdrugstructuredosagenumb120drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext120 MG, QDdrugrecurreadministration3

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Application Number ANDA203023, ANDA075116, ANDA074185, ANDA205231, ANDA075853, ANDA074941, ANDA0904 ... Brand Name DILTIAZEM HYDROCHLORIDE, DILTIAZEM HCL CD, DILTIAZEM HYDROCHLORIDE EXTENDED RELE ... Generic NameDILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETSManufacturers Sun Pharmaceutical Industries, Inc., OCEANSIDE PHARMACEUTICALS, Teva Pharmaceuti ... product_ndc 63304-718, 63304-719, 63304-720, 63304-721, 63304-722, 68682-993, 68682-994, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsDILTIAZEM HYDROCHLORIDERXCUI 830795, 830801, 830837, 830845, 830861, 831054, 831102, 831103, 833217, 1791229, ... spl_id f9671b7a-bf1b-45f5-8d2e-cb834f7395a5, 7ba020e2-1dbc-42f4-8bcd-02cabaacf3a9, 46e3 ... spl_set_id 976d9dd0-4f11-4439-b84e-0c0f0e018d8b, 43892b97-449d-45bc-bb09-29d47c655d65, 69ca ... Package NDC 63304-718-30, 63304-718-05, 63304-718-90, 63304-719-30, 63304-719-05, 63304-719- ... UNIIOLH94387TE

14)

drugcharacterization2medicinalproductPROTONIXdrugdosagetextONE TABLET 30 MINUTES BEFORE FOOD IN THE MORNINGdrugrecurreadministration3

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Application NumberNDA020988, NDA020987, NDA022020Brand NamePROTONIX I.V., PROTONIX DELAYED-RELEASEGeneric NamePANTOPRAZOLE SODIUMManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0923, 0008-2001, 0008-4001, 0008-0841, 0008-0843, 0008-0844Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI283669, 885257, 251872, 284400, 314200, 352125, 763306, 763308spl_id b326d5db-8b20-4ec4-ac25-78190fb3ac36, 1e8fa399-506d-4bcd-9097-dbf7850147bf, 7bdf ... spl_set_id 51e4144a-489e-436c-609a-39305f8f56ba, 5b5ddedd-d429-41a7-8573-10c3e9ad4e52, f39b ... Package NDC 0008-0923-51, 0008-0923-60, 0008-0923-55, 0008-2001-01, 0008-2001-25, 0008-2001- ... UNII6871619Q5X

15)

drugcharacterization2medicinalproductNEURONTINdrugdosagetextTWO PILLS THREE TIMES A DAYdrugrecurreadministration3

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Application NumberNDA020882, NDA020235, NDA021129Brand NameNEURONTINGeneric NameGABAPENTINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0401, 0071-0803, 0071-0805, 0071-0806, 0071-0513, 0071-2012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433, ... spl_id597965f8-e2d2-4010-b57b-482f6e59a810spl_set_idee9ad9ed-6d9f-4ee1-9d7f-cfad438df388Package NDC 0071-0803-24, 0071-0803-40, 0071-0805-24, 0071-0805-40, 0071-0806-24, 0071-0806- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1403USA008346