FDA Panel Rejects Cephalon's Sparlon

Updated from 6:07 p.m. EST

Cephalon's (CEPH Quote) 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. ...