FDA’s Review Progress of Noteworthy Pharmaceutical Products in the Second Half of the Year
II. Drugs that have been completed marketing application but whose PDUFA dates are not determined

According to the disclosed information, besides the drugs mentioned above that are under review, the marketing applications of 4 drugs have been completed, but their PDUFA dates have not been determined, including 1 long-acting factor VIII NN7088, AbbVie’s anti-IL-23A monoclonal antibody risankizumab, and Amgen’s romosozumab that was resubmitted the marketing application.
|
Drug |
Indication |
Mechanism of action |
PDUFA |
Company |
Application type |
Remarks |
|
NN7088 |
Hemophilia A |
factor VIII |
Unknown at the moment |
Novo Nordisk |
BLA |
None |
|
risankizumab |
Moderate-to-severe plaque psoriasis |
Anti-IL-23A monoclonal antibody |
Unknown at the moment |
AbbVie |
BLA |
Completed application on April 25, 2018 |
|
tagraxofusp |
Blastic plasmacytoid dendritic cell neoplasm |
IL-3Rα |
Unknown at the moment |
Stemline Therapeutics |
BLA |
Completed rolling submission on June 25, 2018 |
|
romosozumab |
Osteoporosis |
Anti-SOST monoclonal antibody |
2019 |
Amgen/UCB |
BLA |
Resubmitted application on July 12, 2018 |
III. The indication extension applications of concern
Besides the NDAs/BLAs mentioned above, the indication extension applications of several blockbuster drugs are also listed here, such as the sBLA for Roche’s Tecentriq as first-line therapy for non-squamous NSCLC, and the sBLA for MSD’s Keytruda against squamous NSCLC, which will not be detailed here.










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