AbbVie Receives Complete Response Letter for ABBV-951's NDA to Treat Parkinson's Disease
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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
