Keppra approved for marketing in Japan

posted on:
August 4, 2010


Otsuka Pharmaceutical Co. and UCB have received manufacturing and marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the antiepileptic medication E Keppra in both 250 mg and 500 mg tablets. E Keppra, originally developed by UCB as Keppra, is now marketed in more than 90 countries worldwide, including the United States. E Keppra was approved in Japan as adjunctive therapy in the treatment of partial onset seizures, with or without secondary generalization, in adult patients with epilepsy, who have not had sufficient response to other antiepileptic drugs.

Beginning in 2009, the Food and Drug Administration (FDA) began approving generic versions of Keppra, known as levetiracetam, for marketing in the United States. Generic drugs are tested by the agency to be “bioequivalent,” essentially containing the same active ingredients as the brand name drug. Once generics of Keppra were made available, many health insurance providers ordered pharmacists to switch the brand name product with a lesser expensive generic equivalent.

Formulation switching isn’t uncommon and can save both insurance companies and consumers hundreds of dollars, especially when it comes to medications for chronic conditions. In many cases, switches to generics can be made with few adverse effects.

However, epileptics can be an exception. Some experts say these patients can be more sensitive to subtle changes in inactive ingredients or in how the active ingredient is delivered.  Many patients who have had their seizures controlled with Keppra found that by switching to a generic caused their seizures to return, resulting in injuries and at least one death. 

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