{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "26682300", "primarysourcecountry": "EU", "transmissiondateformat": "102", "transmissiondate": "20260709", "reporttype": "1", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20260428", "receiptdateformat": "102", "receiptdate": "20260428", "fulfillexpeditecriteria": "1", "companynumb": "EU-ALKEM LABORATORIES LIMITED-DE-ALKEM-2025-10251", "primarysource": { "reportercountry": "EU", "qualification": "1" }, "sender": { "sendertype": "6", "senderorganization": "ASCEND" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "29", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "29.0", "reactionmeddrapt": "Seizure", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "29.0", "reactionmeddrapt": "Nausea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "29.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "29.0", "reactionmeddrapt": "Product ineffective for unapproved use", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LACOSAMIDE", "drugbatchnumb": "Unknown", "drugauthorizationnumb": "214695", "drugseparatedosagenumb": "1", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Severe myoclonic epilepsy of infancy", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "LACOSAMIDE" }, "openfda": { "application_number": [ "ANDA204974", "ANDA220268", "ANDA217718", "ANDA204857", "ANDA219699", "NDA216185", "ANDA209465", "ANDA216461", "ANDA214960", "ANDA208466", "ANDA218014", "ANDA218706", "NDA022254", "NDA022253", "NDA022255", "ANDA204787", "ANDA204921", "ANDA214301", "ANDA214695", "ANDA216335", "ANDA213109", "ANDA208308", "ANDA209224", "ANDA215979", "ANDA216151", "ANDA215154", "ANDA215628", "ANDA205031", "ANDA216670", "ANDA209301", "ANDA204994", "ANDA205237", "ANDA218464", "ANDA217311", "ANDA215379", "ANDA205006", "ANDA214677" ], "brand_name": [ "LACOSAMIDE", "LACOSAMIDE ORAL SOLUTION", "MOTPOLY XR", "VIMPAT" ], "generic_name": [ "LACOSAMIDE" ], "manufacturer_name": [ "Alembic Pharmaceuticals Inc.", "GLENMARK PHARMACEUTICALS INC., USA", "Dr. Reddy's Laboratories Inc.", "Amneal Pharmaceuticals of New York LLC", "AvKARE", "Aucta Pharmaceuticals, Inc.", "Zydus Pharmaceuticals USA Inc.", "Zydus Lifesciences Limited", "Kanchan Healthcare Inc", "Ajenat Pharmaceuticals LLC", "Somerset Therapeutics, LLC", "Macleods Pharmaceuticals Limited", "Westminster Pharmaceuticals, LLC", "UCB, Inc.", "Camber Pharmaceuticals, Inc.", "MSN LABORATORIES PRIVATE LIMITED", "Sagent Pharmaceuticals", "Alembic Pharmaceuticals Limited", "Ascend Laboratories, LLC", "XLCare Pharmaceuticals Inc.", "Unichem Pharmaceuticals (USA), Inc.", "Tris Pharma Inc", "Aurobindo Pharma Limited", "Novadoz Pharmaceuticals LLC", "ANI Pharmaceuticals, Inc.", "Chartwell RX, LLC", "Chartwell Governmental & Specialty RX, LLC.", "NorthStar Rx LLC", "Gland Pharma Limited", "Sun Pharmaceutical Industries, Inc.", "Apotex Corp", "NorthStar RxLLC", "Florida Pharmaceutical Products, LLC", "ScieGen Pharmaceuticals Inc", "Marlex Pharmaceuticals, Inc", "Trigen Laboratories, LLC", "Virtus Pharmaceuticals, LLC", "Sintetica US LLC", "Glenmark Pharmaceuticals Limited", "Breckenridge Pharmaceutical, Inc.", "Leading Pharma, LLC", "Indoco Remedies Limited", "Glenmark Pharmaceuticals Inc. 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"31722-547-30", "31722-548-30", "31722-549-30", "31722-550-30" ], "nui": [ "N0000008486", "N0000185506", "N0000182140" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "pharm_class_moa": [ "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "0H73WJJ391" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VALPROIC ACID", "drugbatchnumb": "Unknown", "drugseparatedosagenumb": "1", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Seizure", "activesubstance": { "activesubstancename": "VALPROIC ACID" }, "openfda": { "application_number": [ "ANDA073484", "ANDA075379", "ANDA073229", "ANDA070868", "ANDA073178", "ANDA075782", "ANDA090517" ], "brand_name": [ "VALPROIC ACID", "VALPROIC" ], "generic_name": [ "VALPROIC ACID" ], "manufacturer_name": [ "Bionpharma Inc.", "American Health Packaging", "Upsher-Smith Laboratories, LLC", "Xttrium Laboratories Inc.", "ANI Pharmaceuticals, Inc.", "Chartwell Governmental & Specialty RX, LLC.", "QUAGEN PHARMACEUTICALS LLC", "Actavis Pharma, Inc.", "PAI Holdings, LLC dba PAI Pharma", "Chartwell RX, LLC", "Major Pharmaceuticals", "NorthStar Rx LLC" ], "product_ndc": [ "69452-150", "60687-942", "60687-953", "0832-0310", "0116-4021", "62559-266", "68999-196", "68999-874", "70752-202", "0591-4012", "0121-0675", "0121-4675", "0121-1350", "62135-196", "62135-874", "0904-7620", "0904-7621", "72603-253" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VALPROIC ACID" ], "rxcui": [ "1099681", "1099687" ], "spl_id": [ "52f70fdc-addc-66e3-e063-6394a90a1773", "5839101e-6dae-a58d-e063-6294a90a7b7a", "39829040-e2d4-f4ca-e063-6394a90ace84", "4459a233-1fe1-41dc-e063-6394a90a5ab4", "36e8a44c-2c80-4c44-8cad-9ea6de9807c3", "43f6119e-621e-ca3f-e063-6394a90a562e", "a8e717fe-e79e-46f6-90da-8b8cfe78fae7", "8c8b8043-7c2a-44cc-80e7-fdfa0236287e", "4ba53689-4707-46fc-8943-48f186e04e73", "5071bcb9-2d2f-24e3-e063-6294a90a8e56", "3aea592e-0fb0-4853-83d1-41b2d13c5302", "1286acbf-3497-5aed-e063-6294a90af8be" ], "spl_set_id": [ "ceb52870-76d0-4108-a1d4-ba7096fbacdd", "4b619f73-44e5-4a99-b425-a96cb2228c87", "7d4df6ad-3d53-4664-9200-749487bf3689", "3b124a29-30bd-d30e-e063-6294a90ac4ca", "2314af65-b928-42a9-91eb-6372909ab4f5", "5d19f389-7180-4e01-845f-519b7ea60ba0", "531c0fc7-5e80-49a5-a9d1-0916ec45d52c", "cef3e335-5891-412f-89c4-79fcd2f145b7", "7d5cb52e-37dd-4dfa-a6f4-09f9548846c6", "8051ad62-3b6e-461e-8090-60f5c0a904f4", "a33f7657-ad0f-43e9-ba48-024746e6d08e", "1286ab49-fa34-488e-e063-6394a90ad582" ], "package_ndc": [ "69452-150-20", "60687-942-40", "60687-942-46", "60687-942-77", "60687-942-17", "60687-953-42", "60687-953-48", "60687-953-56", "0832-0310-11", "0116-4021-05", "0116-4021-40", "0116-4021-41", "0116-4021-10", "0116-4021-11", "0116-4021-16", "62559-266-16", "68999-196-45", "68999-196-24", "68999-874-59", "68999-874-24", "70752-202-12", "0591-4012-01", "0121-0675-16", "0121-0675-85", "0121-4675-05", "0121-4675-40", "0121-4675-00", "0121-1350-10", "0121-1350-00", "62135-196-47", "62135-196-45", "62135-196-24", "62135-874-59", "62135-874-24", "0904-7620-41", "0904-7620-94", "0904-7620-70", "0904-7621-66", "0904-7621-72", "72603-253-01" ], "nui": [ "N0000175753", "N0000008486", "N0000175751" ], "pharm_class_epc": [ "Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "unii": [ "614OI1Z5WI" ] } } ] } } ] }