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FDAnews Drug Daily Bulletin

FDA Logs Record Number of Novel Drug Approvals in 2018

Jan. 8, 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.

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