(Recasts, adds share movement)
Dec 19 Indevus Pharmaceuticals Inc IDEV.O
said U.S. health regulators declined to approve its bladder
cancer therapy, Valstar, sending shares tumbling more than 51
percent in late electronic trade to a new year-low.
Valstar was withdrawn from the market in 2002 due to
impurities in the original formulation but the company said
those issues have since been resolved.
The biopharmaceutical company said it received a
non-approvable letter from the U.S. Food and Drug
Administration related to the therapy's chemistry,
manufacturing and controls New Drug Application supplement
submitted in May.
In a statement, the company said during a recent
pre-approval inspection by the FDA of the company's third-party
manufacturing plant for Valstar, some deficiencies were
The company did not disclose where the facility was located
but said upon resolution, which it expects within several
months, it will respond to the FDA and request re-inspection of
Shares of the company fell to $3.50 in late electronic
trade, after closing at $7.16 on the Nasdaq.
(Reporting by Swagata Gupta in Bangalore; Editing by Jarshad
Kakkrakandy, Bernard Orr)