Smaller size capsules of flu drug Tamiflu receive positive opinion in Europe

30mg and 45mg capsules are convenient alternative to suspension for management of seasonal and pandemic influenza in children

Roche announced today that it has received a positive opinion in Europe from the Committee of Human Medicinal Products (CHMP) recommending marketing authorization for Tamiflu (oseltamivir) capsules of 30 mg and 45 mg doses. Until now, Tamiflu was only available in capsules containing a 75 mg dose of oseltamivir and as a powder for oral suspension. The lower dose capsules provide a convenient alternative for the treatment and prevention of influenza types A and B in patients one year and older. Since the capsules have a longer shelf life than the suspension formulation currently used for children (five years vs. two years), they also offer an improved option for government pandemic stockpiling.
An approval for lower dose capsules was recently granted by the U.S. Food and Drug Administration (FDA).
The application for lower dose capsules was filed in February 2007 based on data already available for the 75 mg capsule. 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, oseltamivir, filled into the capsule. The small capsules have longer stability and require considerably less storage space than the currently available paediatric dry suspension. This is critical given the volumes of drug that must be stored and will also facilitate easier distribution in the event of a pandemic.