(August 7, 2006) -- Cephalon Inc. said U.S. regulators rejected its
Sparlon drug as a treatment for
attention-deficit hyperactivity disorder because of safety concerns
and that the company will end development of the product.
The Food and Drug Administration's decision won't affect the 2007 sales and
earnings forecasts, the Frazer, Pennsylvania-based company said today in a
statement. Sparlon is a new formulation of Cephalon's sleep-disorder drug
Provigil.
The company said that it will reserve $8.6 million for Sparlon inventory on
its balance sheet as of June 30. An advisory panel in March had voted against
recommending approval of Sparlon and the agency had been evaluating information
related to a suspected case of a rare, serious skin rash linked to the drug.
Quarterly results reported on Aug. 3 didn't ``reflect the impact of the FDA's
decision today,'' the company said in the statement.
Cephalon shares dropped 10 percent to $57.61 at 5:44 p.m. New York time in
late trading on the Nasdaq Stock Market. They'd fallen $1.30, or 2 percent, to
$63.95 in regular trading.
