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Indevus falls on Nebido delay

June 5, 2008 12:53 AM UTC

Indevus (NASDAQ:IDEV) was off $2.84 (69%) to $1.26 on Wednesday after the company said it expects FDA to request additional safety data prior to approving an NDA for Nebido testosterone depot to treat male hypogonadism. The company said it expects to be required to run an additional study to supply the data and plans to re-file for approval of the long-acting testosterone in about 18 months. Indevus said it will start the study after it receives formal communication from the agency, which the company expects by the June 27 PDUFA date. ...