25.06.2024 14:28:15 - dpa-AFX: AbbVie: FDA Issues CRL For ABBV-951
WASHINGTON (dpa-AFX) - AbbVie (ABBV) said it has 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. The
FDA cited observations that were identified during inspection of a third-party
manufacturer listed in the New Drug Application.
The company noted that the inspection at the facility did not involve ABBV-951
or any AbbVie medicine. AbbVie stated that 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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