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US regulator approves Depakote ER for children

16 September, 2003

The US Food
and Drug Administration
has approved Depakote ER (divalproex sodium extended
release) for use by children with epilepsy.

The tablets have
been approved to treat complex partial seizures in isolation or in
association with other types of seizures and simple
and complex absence seizures in children with epilepsy aged 10
and over. Depakote ER is the once-daily formulation
of
Depakote
(divalproex
sodium
delayed release) tablets, which was originally licensed in the USA in
1983. Depakote ER was approved for epilepsy in adults in 2002.

In a press release
from the manufacturers Abbott
Laboratories
, John
Pellock, professor of pediatrics and neurology at Virginia
Commonwealth University
, said:

"Depakote ER
improves seizure control in adult patients with epilepsy, and it's
exciting
that once-a-day dosing can now offer the same benefit
to children with epilepsy. In a pharmacokinetic study of Depakote ER
in pediatric patients, the clinical researchers found that Depakote ER
produces consistent, therapeutic concentrations of medication throughout
an entire 24-hour cycle. I have also found that once-a-day dosing is
much more convenient for children and their parents."