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9
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English
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Documents
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2013
Description
Eisai's EMEA Operation Becomes the USEisai's EMEA Operation Becomes the US Supply Centre for Epilepsy Drug Zonegran® (zonisamide) PR Newswire HATFIELD, England, October 15, 2013 Japanese pharmaceutical company Eisai today announces that the US Food and Drug Administration (FDA) has approved the US supply of the ®epilepsy drug Zonegran (zonisamide) from its EMEA (Europe, Middle East, Africa, Russia and Oceania) Knowledge Centre based in Hatfield, UK. The Hatfield site will manufacture and package three different strengths of Zonegran tablet for export to the US. The FDA supply approval for zonisamide follows the approval for the US ®supply of another Eisai epilepsy drug, Fycompa (perampanel), on 11 September 2013. The manufacturing facility at Hatfield, which also includes Eisai's EMEA sales and marketing and R&D operations, is increasing in significance to the company's worldwide business as it continues becomes a global supply centre for innovative products such as zonisamide and perampanel. Gary Hendler, President and CEO, Eisai EMEA, comments: "We are pleased to announce this new FDA approval for the US supply of Zonegran from our Hatfield manufacturing facility. This latest achievement, which follows the earlier FDA supply approval for Fycompa, is testament to the commitment our EMEA business has made to the UK." Zonisamide was approved in the US in 2000 as adjunctive therapy for the [1]treatment of partial seizures in adults with epilepsy.
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Publié par
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Publié le
14 octobre 2013
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Langue
English