AbbVie announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) 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 that were identified during 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 and safety trials related to the drug or device-related testing. About ABBV-951 ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous infusion for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

ABBV-951 has been approved in 34 countries and over 2,100 patients worldwide have started treatment. AbbVie continues to work with regulatory authorities around the world to bring ABBV-951 to people living with advanced Parkinson's disease.