ABBV - AbbVie's Parkinson's Disease Therapy Hits FDA Roadblock | Benzinga
Tuesday, AbbVie Inc (NYSE:ABBV) announced it received an FDA Complete Response Letter (CRL) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
In its letter, the FDA cited observations identified during the inspection of a third-party manufacturer listed in the New Drug Application (NDA).
The inspection at the facility did not involve ABBV-951 or any AbbVie medicine.
The CRL does not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device.
The CRL does not request that AbbVie conduct additional efficacy ...