FDA approves distribution of Tamiflu with older package inserts

The FDA recently approved the distribution of two million additional doses of Tamiflu 75 mg containing an older version of the package insert.

"The FDA is working hard to make sure that medicine to treat the flu and its symptoms are available for all who need it," FDA Commissioner Margaret Hamburg said, reports. "Some locations may experience intermittent, temporary shortages of the oral suspension form of the antiviral, Tamiflu, which is the liquid version often prescribed for children for the remainder of the flu season. But the FDA has been working with the manufacturer, Genentech, to increase supply and is reminding healthcare professionals that FDA-approved instructions on the label provide directions for pharmacists on how to make a liquid form of Tamiflu from the Tamiflu capsules if the oral suspension product is not available."

Tamiflu 30 mg and 40 mg capsules are still available, Hamburg said, and pediatric patients one year of age and older can be correctly dosed with those.

"However, pediatric patients less than 1 year of age should be given Tamiflu oral suspension, preferably the commercial oral suspension product or if that isn't available, then the suspension prepared by the pharmacist according to the current label instructions," Hamburg added, according to

Supplies of Tamiflu 75 mg capsules may run low if pharmacies need to make oral suspensions for pediatric patients or to fill large numbers of prescriptions for adult patients.

"So to help avoid a shortage, the FDA is now allowing Genentech to distribute two million units of Tamiflu at the 75 mg capsule level that have an older version of the package insert," Hamburg said, reports. "This additional supply is the same medicine as the product currently in distribution, but does contain an older version of the package insert - it's important to note that this medicine is fully approved. It is not outdated."