FDA Panel Rejects Cephalon's Sparlon
Updated from 6:07 p.m. EST
Cephalon's (CEPH) drug for attention deficit hyperactivity disorder was rejected in a stunning decision by a panel of medical advisers to the Food and Drug Administration.
The advisory committee said Thursday the ADHD medication Sparlon needed more tests to assure safety against a rare and potentially fatal skin disease, even though the experts said the drug was effective. Additional tests could add at least a year to the regulatory process.
The advisory committee voted 12-to-1 against recommending Sparlon's approval, citing its concerns about Stevens-Johnson syndrome, a rare and vicious blistering of the skin that can be caused by certain drugs. The FDA isn't bound to follow its advisers' recommendations, but it usually does so."We are obviously disappointed with the recommendation of the advisory committee," said Dr. Paul Blake, Cephalon's executive vice president for worldwide medical and regulatory operations. "We will continue our discussions with the FDA to determine the next steps in the review of this drug application." In September,
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