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.

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.

2018 will be another big year of FDA review, with the marketing of many blockbuster drugs highly anticipated. The marketing progress of global blockbuster innovative drugs will be further accelerated and the global drug review and approval dynamics are worthier of attention, as the drug review and approval reform of the State Drug Administration of China further advances, especially after the release of the Notice on Soliciting Opinions on the List of Clinically Imperative New Drugs that are Marketed Overseas and the full implementation of acceptance of overseas clinical data in China.

Read more: Drugs Approved by FDA Expected to Exceed 50 in 2018

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