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Published on 11 February 2008

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FDA gives new Zyprexa “green light”

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US government officials have said that a longer-lasting version of Eli Lilly’s best-selling drug Zyprexa is safe and effective for the treatment of schizophrenia.

FDA’s panel of psychiatric experts unanimously voted that the company’s Zyprexa Adhera, an injectable version of the drug, appears safe.

At the moment, Zyprexa is only available as a pill which is taken daily to treat schizophrenia and bipolar disorder.

The new formulation is injected into the muscle and designed to last two to four weeks.

The recommendation is good news for the pharmaceutical firm after the New York Times revealed that the company is in confidential settlement discussions with federal prosecutors who are investigating whether the drug has been marketed properly.

FDA scientists said that while the new version of the treatment appears to work, a small number of patients experienced extreme sedation while taking the drug.

And the agency said that Lilly should do more studies to find the root cause of the side-effect and add cautionary labelling to the product to ensure doctors and patients use it appropriately.

Copyright © PA Business 2008

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