ROCHE FILES EUROPEAN APPLICATION FOR PEDIATRIC TAMIFLU CAPSULES

Roche has filed an application with regulatory authorities in Europe requesting an extension of the current Tamiflu license to include smaller capsules of 30 and 45 mg in addition to the 75-mg capsule already registered.

These lower dosage strengths have been developed mainly for use in children for seasonal and pandemic influenza, as an alternative to the suspension formulation. The small capsules will be better for stockpiling as they have a longer shelf life than the oral suspension, according to the company.

Small Tamiflu (oseltamivir) capsules would also be useful in the elderly adults that have difficulty swallowing the 75-mg capsule. Roche has been granted an accelerated review and is optimistic that European Medicines Agency will complete its evaluation by the middle of this year.

The method of manufacturing will remain the same, and the only change will be the size of the capsule and the amount of the active ingredient in the capsule. The company also plans to submit an application to the FDA.