Hyperactivity

...ba href=/hyperactivity/a/b disorder, or ADHD.

However, FDA officials seemed to be reluctant to require the warning for all the drugs, including those of Britain's Shire Pharmaceuticals Group PLC (SHPGY) and Switzerland's Novartis AG (NVS), which makes Ritalin.

Shire ADRs edged up 0.4% to $47.33, while Novartis rose 1.1% to $56.25.

The FDA is asking its pediatric advisory panel to weigh in with its views a month after its drug-safety advisory panel said the drugs should carry a strict "black-box" warning, relating to the possibility that the drugs increase the risk of heart attacks, strokes and sudden death.

The U.K.'s GlaxoSmithKline PLC's (GSK) inched up 0.7% to $54 after the U.S.

Department of Health and Human Services said it has ordered an additional 2.2 million treatment courses of an antiviral drug from the company that could be used in the event of a possible flu pandemic.

Elan Corp.

(ELN) lost 3.8% to $13.80 after the FDA delayed until the end of June a decision on whether to allow the multiple-sclerosis drug Tysabri back on the market.

The drug's manufacturers, which included Eland and U.S.-based Biogen Idec Inc.

(BIIB), said Wednesday the FDA needed more time to review the proposed risk-management plan for the drug.

The companies had been expecting to hear from the FDA by March 29.

Tysabri was pulled off the market in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died.

A thir...

...ba href=/hyperactivity/a/b disorder.

And that the girl talked about death on two occasions.

The prosecution fired back, pointing out that the little girl wasn't depressed.

The defense claims Monique either committed suicide or took the pills herself.

The prosecution believes Yost murdered her daughter to hide the ultimate family secret: alleged sexual abuse.

Next week the prosecution is going to question a defense witness before he testifies in front of the jury.

The forensic pathologist is expected to testify that a heart defect killed Monique Yost.

That contradicts an autopsy report which states the little girl died of a drug overdose.

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...ba href=/hyperactivity/a/b disorder, documents made public on Wednesday showed, sending company shares down as much as 9.5 percent.

The staff reports were released ahead of an FDA advisory panel meeting on Thursday to discuss the new use of the drug, which is already sold as Provigil to treat sleep disorders.

In October 2005, the agency told the company Sparlon could be approved pending certain conditions.

But one month earlier, a staff reviewer said the drug carries serious risks and should not be approved for ADHD, according to the documents.

"Despite the demonstration of clinical efficacy, the safety profile demonstrates increased and, in this reviewer‘s opinion, unacceptable risks to children and adolescents," he said in a memo dated September 26, 2005.

The FDA has not made a final decision, and is seeking advice from outside experts on whether or not to approve the drug, known generically as modafinil, for ADHD.

Thursday‘s panel meeting will come on the heels of another FDA meeting to weigh the potential risk of psychotic behavior or heart attack with several ADHD drugs, including Novartis AG‘s Ritalin and Johnson & Johnson‘s Concerta, among others.

In a letter sent ahead of Thursday‘s panel meeting, FDA‘s Division of Psychiatry Products Director Thomas Laughren told advisers the agency was concerned about serious skin rashes and psychiatric problems overall, as well as three patients with high liver enzymes.

The agency asked the company for more d...