FDA committee rejects Cephalon's Sparlon

Cephalon shares took a tumble this morning as investors reacted to the news that an FDA advisory committee had rejected an application to market Sparlon for children and adults with ADHD. The committee said it wanted to see more safety data on Sparlon. One of the key pitfalls was data linking the drug to severe skin reactions, including the potentially deadly Stevens Johnson Syndrome. Cephalon lowered its sales projections for the year by $100 million.

"We are obviously disappointed with the recommendation of the advisory committee," said Paul Blake, Cephalon's vice president for regulatory operations. "We will continue our discussions with the FDA to determine the next steps in the review of this drug application."

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PLUS: Regulators are scheduled to making a ruling on Encysive's Thelin for pulmonary arterial hypertension. Analysts expect a positive decision, which would likely have some downside for Actelion's competing therapy Tracleer. Report