Submit Manuscript  

Article Details

Insights into the FDA 2018 New Drug Approvals

[ Vol. 18 , Issue. 2 ]


Alaa Bedair and Fotouh R. Mansour*   Pages 293 - 306 ( 14 )


Objective: The Center of Drug Evaluation and Research (CDER) in the food and drug administration (FDA) approves new drugs every year. This review discusses the novel drugs of the FDA in 2018, with emphasis on the breakthrough drugs, the milestones in the approved list, and drugs with the highest expected sales in 2024.

Methods: The following scientific search engines were surveyed for the clinical trials of the drugs approved by the FDA in 2018: Pubmed, Springer link, ScienceDirect, Scopus, Wiley online library, Taylor and Francis, and Google Scholar. The total forecast sales were compared based on information from the Cortellis database, EvaluatePharma, and Nature Biobusiness Briefs.

Results: The 2018 year was full of good news for the drug market in the USA, with 59 new drug approvals by the FDA, which is the highest number of approvals in the last twenty years. The oncology and the antimicrobial drugs represent almost 50% of the new list, which gives hope to cancer patients and subjects with infectious diseases. In the 2018 FDA list, a number of drugs are expected to exceed 1$ billion dollars of sales by 2024.

Conclusion: The new drugs approved by the FDA in 2018 have been reviewed. This year showed the highest number of new drug approvals in the last two decades. Among the 59 drugs approved in 2018, 14 drugs are considered breakthroughs, which revive hope for many poorly managed diseases. The list also contains 19 drugs that are first in class and 43 that were given priority reviews.


Drug discovery, food and drug administration, 2018 new drug approval list, drug blockbusters, Drug Evaluation and Research (CDER), antimicrobial resistance


Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Sadat City, 32958, Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, 31111

Graphical Abstract:

Read Full-Text article