New Drug Approvals in 2020

(January 11, 2021)

In 2020, the U.S. Food and Drugs Administration (FDA) approved 53 new prescription drugs, the second-highest number of novel drugs approved in one year.  In 2018, 58 novel drugs won U.S. FDA approval. These novel drugs are considered to be "new molecular entities" (NME) or "new therapeutical biological products." Fewer first-time generics were approved this year than last year: 65 first-time generic drugs approved in 2020, compared with 107 first-time generics in 2019. For the complete report on new drugs of 2020, download the FDA's 44-page booklet: New Drug Therapy Approvals 2020. For a recap of 2019's 48 drug approvals, check out


Increase in "Orphan Drug" Approvals
Thirty-one of the 53
new drugs of 2020 were approved under "orphan drug status" --  a special approval path designed to encourage development of drugs that treat rare diseases affecting 200,000 or less people in the U.S.  Additionally, 51 previously-approved drugs received marketing approval under orphan drug status, bringing the total orphan drugs approved in 2020 to 82. Some examples of previously approved drugs gaining new or additional orphan designations in 2020 include Avastin, Imfinzi, Wakix, Opdivo, Simponi, Nucala, Epidiolex, Xywav, Epclusa, and Dificid.


Pursuing orphan drug approvals has become highly popular with drug companies, who seek to re-purpose existing drugs (Humira and Crestor are examples) for niche disease markets, thereby reaping financial benefits like tax write-offs, clinical trials funding, smaller trials, and 7-year exclusive competitive advantage. 933 orphan drug applications have been approved since the Orphan Drug Act's enactment in 1983, about half of them occurring in the last five years. Read about unintended consequences of the Orphan Drug Act, including skyrocketing drug prices, uncovered by a 2017 Kaiser Health News investigation. In 2017, the FDA announced some steps to address the problem, but so far the number of orphan drug approvals has only increased.


Here are the 22 novel drugs approved during 2020 and a brief description of the condition they were approved to treat, followed by a chart of 31 new drugs approved with orphan designations:

List of FDA New Drug Approvals in 2020 - Drug name, treatment reason and dosage route for Non-orphan drugs

List of 31 New Orphan Drug Approvals in 2020 - name, treatment reason and dosage route