The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application (NDA) of ’s ABBV-951 (foscarbidopa/foslevodopa) to treat motor fluctuations in adult patients with advanced Parkinson’s disease. The CRL was issued based on findings from an inspection that did not involve ABBV-951 or any medicine of the company. The gold standard of business intelligence.
The US regulator highlighted findings made during an examination of a third-party manufacturer mentioned in the NDA. AbbVie global therapeutics senior vice-president and chief medical officer Roopal Thakkar stated: “There remains a tremendous unmet need for treatment options for patients living with advanced Parkinson’s disease in the US. “We are focused on working with the FDA to bring this important therapy to patients as soon as possible.
” The CRL found no problems with the efficacy, safety or labelling of ABBV-951, including the device. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form It does not require AbbVie to conduct any additional safety or efficacy trials for the medicine or device.
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