AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)
AbbVie received a Complete Response Letter from the FDA for ABBV-951, a treatment for motor fluctuations in advanced Parkinson's disease, due to observations during inspection of a third-party manufacturer. The CRL does not raise issues on safety, efficacy, or labeling of ABBV-951.
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AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)
AbbVie received a Complete Response Letter from the FDA for ABBV-951, a treatment for motor fluctuations in advanced Parkinson's disease, due to observations during inspection of a third-party manufacturer. The CRL does not raise issues on safety, efficacy, or labeling of ABBV-951.