www.fdanews.com/articles/189757-fda-logs-record-number-of-novel-drug-approvals-in-2018
FDA Logs Record Number of Novel Drug Approvals in 2018
January 7, 2019
The FDA approved a record number of novel drugs in 2018, continuing a mostly upward trend over the past decade.
The agency granted 46 novel drug approvals in 2017 — at the time, the most approved in a single year for two decades — but it topped that record last year with 59 approvals.
Approvals included Teva’s Ajovy (fremanezumab-vfrm), an injectable migraine treatment for adults, Theratechnologies’ Trogarzo (ibalizumab-uiyk), an HIV drug for patients with limited options, and Xofluza (baloxavir marboxil), a new influenza medication, and six new leukemia treatments.