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AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)
AbbVieAbbVie(US:ABBV) Prnewswire·2024-06-25 20:15

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 facilitiesThe 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 testingAbbVie continues to work with the FDA to bring ABBV-951 ...