FDA Approves Roche’s Low-Dose Tamiflu

Roche received approval from the FDA for its sNDA to market Tamiflu capsules in 30 mg and 45 mg doses. The lower dose capsules provide an alternative for the treatment and prevention of influenza types A and B in patients one year and older. The capsules also have a longer shelf life than the liquid suspension formulation, offering an improved option for pandemic stockpiling.

The sNDA was filed in March based on data already available for the 75 mg capsule. The method of manufacturing will remain the same. The 30 mg and 45 mg capsules will be available in pharmacies nationwide for the 2007-2008 flu season.