AbbVie received a Complete Response Letter from the FDA for the New Drug Application for ABBV-951 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 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.
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