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.