Eisai Introduces Granulated Tambocor in Japan
Japanese drugmaker Eisai on Friday launched a granulated formulation of its antiarrhythmic agent Tambocor to treat children with rapid heart rate.
The formulation can be adjusted for age and size for use in pediatric patients and will benefit patients who can’t swallow tablets, the firm said.
The tablet form of Tambocor (flecainide acetate) was launched in Japan in 1991 for treating adults and was approved for pediatric patients in 2010.
Eisai received approval for the granule pediatric formulation on Feb. 16, and the product was added to Japan’s National Health Insurance list on June 19.
Pediatric arrhythmia is one of the most common causes of sudden death among children, Eisai said.
In the U.S., Boehringer Ingelheim’s Roxane Laboratories subsidiary received FDA approval for Tambocor in January 2003. — Kellen Owings