Aurobindo's Generic Rufinamide Receives Approval in the U.S.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received notification from Japan’s Ministry of Health, Labour, and Welfare (MHLW) that the “all-case study” specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon® Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared.
Aurobindo's Generic Rufinamide Receives Approval in the U.S.
Lupin today received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Rufinamide Tablets USP, 100 mg, 200 mg, and 400 mg, to market a generic equivalent of Banzel Tablets, 100 mg, 200 mg, and 400 mg, of Eisai Inc.
Lupin's Generic Rufinamide Receives Approval in the U.S.
Lupin`s Generic Rufinamide Receives Approval In US
Lupin Limited has received approval for its rufinamide oral suspension, 40 mg/mL, from the United States Food and Drug Administration (FDA), to market a generic equivalent of Banzel oral suspension, 40 mg/mL, of Eisai Inc.
Hikma`s Generic Rufinamide Receives Approval In US
Bionpharma`s Generic Rufinamide Receives Approval in US
West-Ward Pharms's Generic Rufinamide Receives Tentative Approval in US