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Biotech / Medical : MEDX ... anybody following?
MEDX 31.15-0.3%Nov 3 1:15 PM EST

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From: Icebrg8/9/2008 2:45:12 AM
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Johnson & Johnson drug review delayed by 3 months
August 8, 2008

NEW BRUNSWICK, N.J.—Johnson & Johnson's Centocor unit said Friday the Food and Drug Administration will take an additional three months to review an application for the experimental psoriasis drug ustekinumab.

The company said the review could now run through December. Centocor is seeking approval of the drug for adult patients with chronic moderate to severe plaque psoriasis, a severe skin disease. The FDA extended the review period because of application amendments made over the last three months.

In June, an FDA advisory panel unanimously recommended approval. The regulatory agency normally follows the recommendations of its advisory panels, though it is not required to do so.
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