oseltamivir

Gilead Sciences, Roche withdraws European filing

Roche has announced the withdrawal of its European application for approval of the neuraminidase inhibitor oseltamivir (TAMIFLU) for the treatment of influenza. The decision to withdraw this filing follows questions raised by the CPMP which require the submission of additional data. Roche believes withdrawing the application will allow the company time to provide this information to the European regulatory authorities. The application will be resubmitted as soon as possible. Oseltamivir was codeveloped by Roche and Gilead Sciences. The product was first launched for the treatment of influenza in Switzerland October 1999 and has subsequently been marketed in the USA, Canada and most Latin American countries.

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Lead Story from Drug News, 05 Jun 2000.

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