FDA clears Eisai Zonegran facility in UK for US exports

Japanese pharma major Eisai (TYO: 4523) says the US Food and Drug Administration 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 USA.

The FDA action follows the approval last month for the US supply of another Eisai epilepsy drug, Fycompa (perampanel; The Pharma Letter September 11). 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 center for innovative products such as zonisamide and perampanel.

Gary Hendler, president and chief executive of 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."