AbbVie Receives A Complete Response Letter From U.S. FDA For The NDA For ABBV-951, For The Treatment Of Motor Fluctuations In Adults With Advanced Parkinson's Disease

Author: Benzinga Newsdesk | June 25, 2024 08:17am

U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for ABBV-951 based on observations from an inspection that did not involve ABBV-951 at one of AbbVie's third-party manufacturing facilities
The CRL does not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device, and does not request that AbbVie conduct additional efficacy or safety trials related to the drug or device-related testing
AbbVie continues to work with the FDA to bring ABBV-951 to patients in the U.S. as quickly as possible

NORTH CHICAGO, Ill., June 25, 2024 /PRNewswire/ -- AbbVie (NYSE:ABBV) today 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.

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