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Orexo AB Reports Positive Feedback from Pre-NDA Meeting With FDA - Clearing Path for Regulatory Submission of OX219


7/23/2012 10:14:05 AM

UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: A meeting with the US regulatory agency FDA held on July 17 has confirmed that the Swedish pharmaceutical company Orexo (STO:ORX) is on track with its preparation for a regulatory submission of a new drug approval (NDA) for its medicine for treatment of opioid dependency, OX219. The meeting was a scheduled pre-NDA consultation and was undertaken to review critical regulatory issues, including adequacy of the clinical program and pre-clinical documentation, as well as the planned documentation on the product including the chemistry, manufacturing and control (CMC) plans, prior to submission of the actual documentation.

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