Roche/Gilead file for Japanese Tamiflu OK
Hoffmann-La Roche and Gilead Sciences have filed for regulatory approvalof their neuraminidase inhibitor Tamiflu (oseltamivir) with the Japanese Ministry of Health and Welfare. The firms are seeking clearance to market Tamiflu for both the treatment and prevention of influenza A and B in adults.
Tamiflu, the main competitor to Glaxo Wellcome's inhaled product Relenza (zanamivir), is already available in a number of countries as a therapeutic, including the USA, Canada and Switzerland. Furthermore, it has been submitted for the prophylaxis indication in Canada and the USA, where the firms are also seeking labeling for children aged one year and older.
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