Roche Offers The FDA Additional MIRCERA(R) Data
Published: Dec 15, 2006
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.