The press release announcing the deal trumpeted that Sabril was in the final stages of FDA review.

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Even now, Ovation's parent company, Lundbeck, will probably make more from selling Sabril to adult epileptics than to babies.

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New conflict of interest rules led it to cancel a July 2008 panel for Sabril because one key expert no longer qualified.

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Forty percent of the patients who take Sabril have this side effect.

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But from the outset, the agency said it would need extra time to convene a panel of experts to weigh Sabril's merits.

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After a first treatment failed, Jake was helped by an experimental medicine called Sabril that carried the risk of destroying his peripheral vision.

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But Sabril needed a Risk Evaluation and Mitigation System (REMS), FDA jargon for a plan that ensures drugs are only used when benefits outweigh risks.

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Sabril warrants close attention because it's a clear near-miss for the drug approval system, a case where a medicine with a clear benefit for desperate patients foundered.

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The FDA finally convened its panel in January 2009, and the panelists voted unanimously that Sabril should be approved both for babies with infantile spasms and for adults who had run out of options.

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That would have been that had it not been for Donald Shields, director of the pediatric epilepsy program at UCLA. In 1996, Shields and his colleague Roy Elterman had started a study of Sabril in infantile spasms.

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Sabril was finally approved in August.

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He sold them on Sabril.

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