FDA’s Review Progress of Noteworthy Pharmaceutical Products in the Second Half of the Year

Author: 1℃

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.

Read more: FDA’s Review Progress of Noteworthy Pharmaceutical Products in the Second Half of the Year

--------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: [email protected].