AbbVie (ABBV) Parkinson's Candidate Faces 2nd FDA Rejection
AbbVie (ABBV) announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA) seeking approval for ABBV-951 for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). This is the second CRL issued for ABBV-951 by the FDA.The latest CRL was based on some observations on inspection of one of AbbVie's third-party manufacturing facilities listed in the NDA. The inspection did not involve ABBV-951 or any other AbbVie drug. The FDA has not requ ...