Mylan Sues FDA For Delaying Duragesic Generic

Law360, New York (June 23, 2004, 12:00 AM EDT) -- Mylan Laboratories Inc. has sued the U.S. Food and Drug Administration for delaying introduction of the company's generic version of Johnson & Johnson’s Duragesic pain-relief skin patch.

The largest U.S. generic drug maker also suspended its earnings forecast on Wednesday as its shares fell on the news that the company would not be able to sell the skin patch as early as previously indicated.

On Tuesday, the FDA granted Johnson & Johnson, which makes Duragesic, an additional six months of marketing exclusivity for the treatment. That...
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