Posted by Michael Wonder on 13 Jun 2024
Receipt of complete response letter from US FDA for ND0612
11 June 2024 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for the new drug application of investigational ND0612 for the treatment of motor fluctuations in people with Parkinson’s disease which is being developed by its wholly owned subsidiary, NeuroDerm.
Mitsubishi Tanabe Pharma is currently reviewing the complete response letter and will work closely with the FDA to address its comments to consider the future direction.
