Summary: In 2019, the U.S. FDA approved a total of 47 lyophilized drug applications submitted by 37 companies. Information on generic drugs was compiled from FDA’s Orange Book database, not including drugs listed with any of the following conditions: discontinued, solution dosage form, routes of inhalation, oral, spinal, and intrathecal administration. Overall, 87% (41) of the FDA approved lyophilized drugs are generic products, followed by 9% (4) new drug applications (NDA) and 4% (2) of new biologics. By indication, oncology comprised the largest category of FDA approved lyophilized drugs at 47%, followed by infectious disease (34%), surgical use (7%), and others (metabolic, virology, neurology, diagnostics use, digestive, and rare diseases) at 2% each in 2019. Additionally, in 2019 EMA approved 4 lyophilized drugs for oncology (2), infectious (1), and metabolic (1) diseases. The following tables and infographics are constructed from data collected from the European Medicine Agency website, U.S. Food and Drug Administration websites and databases, and DailyMed website, all accessible online.

Yirang Park and Helen Corbat, Purdue University

Researchers should cite this work as follows:

• Jennifer Gray (2020), "Lyophilization in Review 2019," https://pharmahub.org/resources/851.

  BibTex | EndNote

1. Lyohub
2. Lyophilization
3. Pharmaceutical manufacturing