US FDA delays approval of Cephalon's Sparlon, firm cuts 2006 sales projections

US drugmaker Cephalon says that a US Food and Drug Administration expert committee has advised against the approval of its drug candidate Sparlon (modafinil) tablets for the treatment of attention-deficit hyperactivity disorder in children and adolescents.

In light of the move, the company has reduced its 2006 sales guidance by $100.0 million to $1.45-1.50 billion. As a result, projected sales within its central nervous system franchise were also dropped, to $665.0-715.0 million.

Cephalon had hoped to launch the drug this year but, despite the delay the firm says it will not change its previously-issued 2006 basic adjusted income guidance, which remains at $3.80-$4.00 per common share. Chief executive Frank Baldino, explained that cash saved from Sparlon's introduction will offset the loss in sales.