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Roche (RHHBY) Offers The FDA Additional MIRCERA(R) Data



12/15/2006 11:13:25 AM

NUTLEY, N.J., Dec. 15 /PRNewswire/ -- Roche today announced that it has submitted additional data to the FDA to support its Biologic License Application (BLA) for MIRCERA®. These data offered are intended to provide as comprehensive an understanding of MIRCERA as is possible to assist the FDA in completing the review process. As a result of this action, the FDA has granted Roche a three month extension to the review period.

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