FDA delays release of Genzyme's Synvisc-One
CAMBRIDGE, Mass. Genzyme, a biotech company has announced that the Food and Drug Administration has delayed the release of the company’s new osteoarthritis drug, Synvisc-One because, the agency wants more analyses and data on the drug.
Synvisc-One is intended to provide six months of pain-relief from osteoarthritis of the knee with each dose. The longer-lasting formulation would provide more convenience to patients and reduce overall costs, according to Genzyme.
The company now has to push back the launch date of the drug to at least the second half of 2008.