The Hatfield site will manufacture six different tablet strengths of the drug, a leading epilepsy treatment, for the US market.
The FDA approval reflects the growing investment of Japanese company Eisai in the UK as a global drug manufacturing base – and also an R&D base, since Fycompa was jointly developed by the UK and Japanese operations.
Gary Hendler, CEO of Eisai EMEA, said: “The FDA approval for the supply of our epilepsy drug perampanel is testament to the commitment we have made at our EMEA Knowledge Centre and the Hatfield manufacturing facility.
“The UK is a competitive location for advanced manufacturing and packaging and I am delighted that we are now able to export products developed and manufactured here in the UK to the US.”
Eisai established the £100m EMEA Knowledge Centre at Hatfield, Hertfordshire, in June 2009 to integrate the company’s R&D, production, marketing and EMEA headquarters functions.
Fycompa, approved as an adjunctive treatment for partial onset seizures, is one of four anti-epilepsy drugs marketed by Eisai in the EMEA region.
Eisai EMEA has sales operations in over 20 countries, including the UK.