Roche seeks approval for child-size Tamiflu

Swiss drug major Roche has filed an application with the European Medicines Agency (EMEA) to approve child-sized capsules of Tamuiflu (oseltamivir). The firm is requesting an extension to its current license to include smaller 30mg and 45mg capsules in addition to the 75mg dosage 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.

Roche said that smaller Tamiflu capsules would also be useful in the elderly or other adults that have difficulty swallowing the 75mg size. Roche has been granted an accelerated review and is optimistic that the EMEA will complete its evaluation by the middle of the year. An application will also be filed with the US Food and Drug Administration. The application was filed based on information already available for the 75mg capsule. The firm noted that 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 it contains.