U.S. FDA approves film-coated nelfinavir mesylate (Viracept™)
Agouron Pharmaceuticals, Inc. have announced that the Food and Drug Administration (FDA) has approved a film-coated tablet version of Nelfinavir Mesylate (ViraceptTM).
This new formulation follows criticism that the current version was dry, chalky, difficult to swallow and had a tendency to break easily during storage. The dosage strength will remain the same.
Whilst film coated nelfinavir is now on pharmacy shelves in the US, the dossier for European approval has not even been submitted to regulatory authorities. This delay means it is unlikely that Europeans will benefit from the improved tolerability of this formulation before sometime next year. The reason for these delays is unknown. Roche Pharmaceuticals are responsible for nelfinavir in Europe.
A ‘hardened’ version of nelfinavir will be distributed in Europe from May this year as an intermediate step to improve the usability of this drug.