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Dec 19 (Reuters) - 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Valstar was withdrawn from the market in 2002 due to impurities in the original formulation but the company said those issues have since been resolved.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 identified.
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 the facility.
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)