Medication Monitor

Generic Name (Trade Name—Company)
July 11, 2011


New concentration for oral suspension


The concentration of oseltamivir suspension will be changed from 12 mg/mL to 6 mg/mL, FDA has announced. This lower concentration is less likely to become frothy when shaken and will help with accurate measurements of the liquid, the agency said. Additional changes include the measurements on the oral dosing device, which will be switched from mg to mL; a change in the dosing table to include a column for dosing (mL) based on this new concentration; revised container and carton packaging; and compounding instructions for preparation of a 6 mg/mL oral suspension in emergency situations when the commercially marketed product is unavailable. 


The 12 mg/mL concentration will no longer be marketed once the current supply runs out, and Genentech has instituted a voluntary Take Back Program for wholesalers, distributors, and pharmacies to remove product of the older concentration from the market. FDA notes that both concentrations may be available in the pharmacy for the 2011-12 influenza season, and health providers must be aware of this issue and to take steps to avoid medication errors as a result of confusion between the two concentrations.