UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News:
Orexo (STO:ORX)
Orexo AB (publ) announces today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for an expanded label of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) to include initiation of treatment for opioid dependence. Orexo anticipates a potential approval of the expanded label during the third quarter 2015.
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