Shots:

• The US FDA has issued a Complete Response Letter (CRL) for ABBV-951 (foscarbidopa/foslevodopa)'s NDA to treat motor fluctuations among advanced Parkinson's disease adults
• The letter stated observations from an inspection of a third-party manufacturer in the NDA, which did not include ABBV-951 or any AbbVie medicine. No concerns were raised regarding ABBV-951’s safety, efficacy or labeling and is not requesting studies confirming its safety & effectiveness or device-related testing
• ABBV-951 is a solution comprising of carbidopa and levodopa prodrugs, being developed for 24-hour continuous SC administration among PD adults

Ref: AbbVie | Image: AbbVie

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