Swedish pharmaceutical company Orexo plans to submit OX219, a treatment for opioid dependency, for FDA approval in the U.S.
According to a company release, Orexo is now "on track" to seek approval following an initial consultation with the regulatory organization, which reviewed the clinical program, pre-clinical documentation and manufacturing and control plans for the drug.
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According to a company release, Orexo is now "on track" to seek approval following an initial consultation with the regulatory organization, which reviewed the clinical program, pre-clinical documentation and manufacturing and control plans for the drug.
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