Hyperactivity

...ba href=/hyperactivity/a/b disorder.Despite a unanimous vote in favor of the drug's efficacy, the FDA committee voted 12-1 against approval, citing safety concerns regarding potential skin rashes.Cephalon (nasdaq: CEPH - news - people ) lowered fiscal 2006 sales guidance by $100 million following news of the panel's decision but maintained earnings-per-share guidance of $3.80 to $4.00.

The company said during a conference call late Friday it will provide an update on the status of Sparlon after it holds discussions with the FDA.Ken Kulju of Credit Suisse is forecasting a delay of 15 months for Sparlon and expects the drug to enter the market with label restrictions, which will put a damper on commercial uptake."While difficult to gauge exactly the scope of the trial that the FDA will demand from Cephalon, we believe that the agency will probably take one committee member’s suggestion for a 3,000-patient safety study to address these concerns," he said."The loss of the Sparlon growth driver removes a critical 2007 growth driver, with Credit Suisse now anticipating a flat earnings profile moving from 2006 to 2007."Despite the disappointing news, Kulju said he believes Cephalon has "adequate financial flexibility to offset Sparlon sales in 2006." Still, the analyst lowered the 2007 EPS estimate to $2.98 from $3.30.Kulju said a valuation analysis of the stock indicates Cephalon should trade at 22 times future earnings, "implying a stock trading range of $64 to $65."Cephalon said yest...

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TCV Exclusive News US News International Politics Strange Business Health TCV News Military TCV News Doctors Call for ADHD Drugs Warning March 24, 2006 10:12 AM EST By Sher Zieve – Pediatricians and pediatric experts called upon the FDA to issue additional warnings for drugs used to treat the controversial condition Attention Deficit ba href=/hyperactivity/a/b Disorder in children.

The drugs used to treat the disorder are said to have caused manic episodes, hallucinations, other psychotic conditions and aggressive behavior in the children who take them.

Use of the stimulant drugs are also reported to have caused suicidal thoughts in some children and the FDA has received hundreds of reports of extremely aggressive behaviors from others.

Lauren L.

Leslie MD, of the Child and Adolescent Services Research Center in San Diego, said: "Take the child off of it, see what happens.

Those are messages we don't give out enough.” Post a Comment More Commentary | Return to Home Page © 2005-2006 The Conservative Voice.

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