FDA analysis raises concerns about Synvisc-One trial

12/8/2008 | Reuters

FDA staff expressed concerns about Genzyme's study of Synvisc-One, a single-dose version of its injectable treatment for osteoarthritis of the knee, saying it was conducted in a small population and did not undergo adequate agency evaluation because it took place in Europe. The review, however, said the medicine seems as safe as the older formulation. An advisory committee will meet Tuesday to consider Synvisc-One for approval.

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