GlaxoSmithKline’s Epilepsy Drug given the Green Signal by FDA

by Medindia Content Team on  September 26, 2006 at 5:06 PM Drug News   - G J E 4
GlaxoSmithKline’s Epilepsy Drug given the Green Signal by FDA
The Food and Drug Administration. has given GlaxoSmithKline PLC's anti-seizure medicine to treat Primary Generalized Tonic-Clonic, or PGTC, the green signal.

According to GlaxoSmithKline, the U.K. pharmaceutical company, the drug, Lamictal, has been approved to treat children age two and older, as well as adults.

PGTC seizures are said to be the most-serious and most-commonly occurring type of generalized seizures, seen in about 20% of patients with epilepsy.

Epilepsy is a recurrent, unprovoked seizure characterized by a change in sensation, awareness, or behavior which comes about by an electrical disturbance in the brain.

Lamictal has now received the fifth FDA approval. It been approved to treat partial and generalized seizures and as well as for use as maintenance therapy for adults with bipolar disorder.

The FDA's approval is said to have been based on a multicenter trial in pediatric and adult patients, which proved to be "highly effective" in reducing the frequency of generalized tonic-clonic seizures by 66%.

Source: Medindia

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