FDA slaps CRL on Mitsubishi Tanabe’s investigational ND0612
Japan’s Mitsubishi Tanabe Pharma (MTPC) yesterday announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) of its investigational ND0612.
The drug is intended for the treatment of motor fluctuations in people with Parkinson’s disease, which is being developed by its wholly-owned subsidiary, Israel-based NeuroDerm.
The FDA has issued observations regarding the manufacturing site and the non-clinical information for ND0612. In response, MTPC Group will continue to work closely with the FDA on the resubmission and remains committed to bringing new treatment options for people living with neurodegenerative diseases in the central nervous system, one of the key areas of focus for R&D.
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