Epilepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-01-29FDA Approved: CARBAMAZEPINE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for carbamazepine by Rising Pharma Holdings, Inc.
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EMA safety_alert · 2024-01-26Precautionary measures to address potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
EMA safety precautionary measures advise restricting valproate use in men prior to conception due to possible risk of neurodevelopmental dis…
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FDA approval · 2024-01-24FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for levetiracetam (generic) submitted by Lupin Pharmaceuticals, Inc. under the ANDA.
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FDA approval · 2024-01-24FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for levetiracetam, a generic anti-seizure medication, from BluePoint Laboratories.
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FDA approval · 2024-01-24FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for levetiracetam by Lupin Pharmaceuticals, Inc., supporting a generic product. This action upda…
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FDA approval · 2024-01-24FDA Approved: LEVETIRACETAM — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for levetiracetam submitted by NorthStar RxLLC.
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FDA approval · 2024-01-24FDA Approved: LEVETIRACETAM ER — Supplemental Application (Westminster Pharmaceuticals, LLC)
FDA approved a supplemental application for LEVETIRACETAM ER from Westminster Pharmaceuticals, LLC.
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FDA approval · 2024-01-24FDA Approved: GABAPENTIN — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approves the Gabapentin original ANDA from Zydus Pharmaceuticals USA Inc.
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FDA approval · 2024-01-24FDA Approved: LACOSAMIDE — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's lacosamide Original Application (ANDA), enabling the marketing of a generic lacosamide product. Laco…
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FDA approval · 2024-01-23FDA Approved: PRIMIDONE — Original Application (Carnegie Pharmaceuticals LLC)
FDA approved the original ANDA for primidone from Carnegie Pharmaceuticals LLC. Primidone is an anticonvulsant used in the treatment of cert…
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FDA approval · 2024-01-18FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited. The action updates the product labeling and may expa…
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FDA approval · 2024-01-17FDA Approved: GABAPENTIN — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original application for gabapentin, a generic version of the anticonvulsant used for partial seizures …
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FDA approval · 2024-01-12FDA Approved: LEVETIRACETAM — Supplemental Application (Granules Pharmaceuticals Inc.)
The FDA approved a supplemental application for levetiracetam from Granules Pharmaceuticals Inc., authorizing an additional formulation/stre…
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EMA guidance · 2024-01-12Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024
PRAC highlights potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines and recommends preca…
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FDA approval · 2024-01-09FDA Approved: CARBAMAZEPINE — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for carbamazepine by Upsher-Smith Laboratories, with changes to its approved labeling and indication…
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FDA approval · 2024-01-04FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)
The FDA approved a supplemental application for TROKENDI XR (topiramate) filed by Supernus Pharmaceuticals, Inc., updating the product's lab…
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FDA approval · 2024-01-04FDA Approved: TOPIRAMATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Topiramate from Aurobindo Pharma Limited under an ANDA for an already approved generic product.
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FDA approval · 2023-12-27FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited under an ANDA.
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FDA approval · 2023-12-22FDA Approved: CARBAMAZEPINE — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)
FDA approved a supplemental application for Carbamazepine from NIVAGEN Pharmaceuticals, authorizing changes to the generic product under the…
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FDA approval · 2023-12-22FDA Approved: LACOSAMIDE — Original Application (Glenmark Pharmaceuticals Limited)
FDA approved Glenmark's lacosamide generic drug under an Original Application (ANDA 215379). Lacosamide is indicated as adjunctive therapy f…
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CLINICAL_TRIALS trial_result · 2023-12-14Clinical Trial Update: Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures [Phase 3]
Phase 3 trial evaluating lacosamide as add-on therapy for epileptic tonic-clonic seizures; completed with results posted.
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FDA approval · 2023-12-11FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for FINTEPLA (fenfluramine) filed by UCB, Inc., expanding/adjusting its labeling and indications.
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FDA approval · 2023-12-11FDA Approved: CARBAMAZEPINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for carbamazepine filed by Unichem Pharmaceuticals (USA), Inc., signaling an approved change to …
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FDA approval · 2023-12-07FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original ANDA for eslicarbazepine acetate, a generic anticonvulsant, for use as adjunctive therapy in adults wit…
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FDA approval · 2023-12-05FDA Approved: TOPIRAMATE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approves an original abbreviated application for Topiramate from Upsher-Smith Laboratories, establishing a generic formulation of the an…