“We believe Xeomin can help manage excessive drooling, and we look forward to continuing to work closely with the FDA as they review our application.” The sBLA is based on a Phase III, randomized, ...
The sBLA approval was based on data from a phase 3 study evaluating Xeomin in 216 patients aged 6 to 17 years with chronic sialorrhea associated with cerebral palsy, other genetic or congenital ...
RALEIGH, N.C.--(BUSINESS WIRE)--Merz Americas announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XEOMIN ® ...
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