Roche announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to market Tamiflu (oseltamivir phosphate) capsules in 30 mg and 45 mg doses. 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 liquid suspension formulation (five years vs. 24 months), they also offer an improved option for government pandemic stockpiling.
Tamiflu will continue to be available in a 75 mg capsule for adults as well as liquid suspension formulation for children. The 30 mg and 45 mg capsules will be available in pharmacies nationwide and for government stockpiling for the 2007-2008 flu season. To date, Roche has filled orders from the US federal government and states for 43.7 million Tamiflu treatment courses.
"Roche continues to take steps to facilitate the use of antivirals in pandemic preparedness and response," said Dominick Iacuzio, Ph.D, medical director at Roche. "These lower dose capsules not only provide governments with a new option for pandemic stockpiling, but also give prescribing physicians an alternative for patients who prefer a capsule formulation."
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 only change will be the size of the capsule and the amount of the active ingredient, oseltamivir phosphate, filled into the capsule. Tamiflu is the only neuraminidase inhibitor approved for use in children one to five years of age.
The Centres for Disease Control and Prevention (CDC) recommends three steps to protect against influenza: vaccination, good health/hygiene habits, and antiviral medications. When taken within 12-48 hours of symptom onset, antiviral medications like Tamiflu can help reduce the duration of symptoms.
Roche has donated 5.1 million Tamiflu treatment courses to the World Health Organization to contain an initial pandemic outbreak and granted four sub-licenses for production to companies in China, India and Africa.
Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, is a systemic treatment for the most common strains of influenza (types A and B). Tamiflu is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients one year and older who have had flu symptoms for no more than two days.