Zyprexa

“I guess my up-front message, front and center,” she continued, “is that you know that ADHD drugs can cause serious side effects and death, including sudden death, hypertension, myocardial infarction, stroke, and possibly bipolar disorder.

“This being the case,” she said, “I urge you to recommend that these drugs have an appropriate black box warning placed on the label starting immediately.” Sandra Lucas appeared at the hearing to speak on behalf of the Citizens Commission on Human Rights, a psychiatric watchdog group, and told the panel, “We do know that the side effects of the stimulants are not only present, they are extremely serious and sometimes lethal.” “So,“ she asked the committee, “while the FDA ponders the problem of studying the issue and conducting the studies that may have inherent flaws, what real, immediate protections are to be put in place for parents and children?

” During the hearing, Drug Safety panel member Dr Art Levin told the committee, “I think we have to recognize that when a drug is approved and marketed the public assumes a level of comfort in the safety of that drug unless they are told otherwise.” “And, for us to sit around and talk about this,” he...

Analysts at Morgan Stanley presented a rosier picture.

In a report issued last month they reiterated their 'overweight' rating on Barr and raised the target price from $70 to $75.

Barr spokeswoman Carol Cox said the company had not heard from the FDA regarding Plan B and Clinton`s and Murray`s attempt to force action on the issue.

'We provided our public comment back in November ...

and that`s the last interaction we`ve had with the FDA,' Cox told United Press International.

She said Seasonale sales were 'doing very well' and the drug was showing 'record prescriptions on a weekly basis.' Danco is facing a potentially bleaker scenario.

The two additional deaths, which were announced late last week, bring the total number of fatalities associated with Mifeprex to seven in North America.

Several conservative congressmen and anti-abortion-rights groups have called for the drug to be taken off the market, although there does not appear to be any evidence to conclusively indicate the cause of the deaths was Mifeprex.

The FDA said it was investigating the latest two fatalities and was not able to...

"The news is also good for big pharma in general as one of trends in recent years is generic companies setting out to sell drugs potentially years before the patents actually expire on the branded products," McGowan said.

Under terms of the proposed Apotex settlement, Sanofi-Aventis would grant Apotex a royalty-bearing license to sell clopidogrel bisulfate in the United States once the patent expires in 2011.

Clopidogrel is the chemical name for Plavix.

Plavix is by far the biggest product for the drugmakers, with Bristol reporting about $3.8 billion in 2005 U.S.

Plavix sales, and the possibility that it could lose patent protection had been a huge uncertainty hanging over them.

The drug had 2005 worldwide sales approaching $6 billion, according to data released by IMS Health Inc.

(RX.N: Quote, Profile, Research) Continued ...

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