(Bloomberg) -- AbbVie Inc. failed to win approval for a new Parkinson’s disease drug after US regulators found problems at a third-party manufacturing facility.

An inspection by the Food and Drug Administration uncovered issues at the facility that were unrelated to any AbbVie drugs, the company said Tuesday in a statement. As a result, regulators issued a complete response letter for ABBV-951, a device-drug combination that infuses two drugs to help control symptoms of Parkinson’s.

AbbVie said it’s working with the FDA to bring the drug to market as soon as possible, though the company didn’t say how long it expects the delay to last. The FDA didn’t identify any problems with the safety or effectiveness of the drug, and it didn’t request new studies, AbbVie said.

This is the second time ABBV-951 has been delayed in the US. In March 2023, the FDA requested additional information about the pump. 

The device-drug combination is already approved in Europe.

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