Posted by Michael Wonder on 25 Oct 2025
Receipt of complete response ketter from US FDA for investigational ND0612
23 October 2025 - 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.
The FDA has issued observations regarding the manufacturing site and the nonclinical information for ND0612.
