FDA approves first drug for infantile spasms

August 21, 2009

(AP) -- The Food and Drug Administration has approved the first drug to treat infantile spasms, a rare disorder that can cause hundreds of seizures per day in children less than a year old.

Sabril is an oral solution from Deerfield, Ill.-based Lundbeck Inc. approved for children between the ages of 1 month and 2 years. Infantile spasms usually occur while babies are eating or waking up, and often come in clusters of up to 100.

FDA director of neurology products Russell Katz says: " in this young are very serious and this approval provides these patients and their parents a treatment option."

The FDA also approved a Sabril tablet to treat seizures in adults who have not responded to other drugs.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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