NorthWest Biotherapeutics Inc (NWBO)

[GermanCol]

The assignment of generic names to pharmaceuticals in development is an important prerequisite to marketing a drug.

In the United States, the FDA recognizes the USAN as the legal name for the active drug ingredient, and the USAN appears in the titles of monographs published by the USP that define the standards, properties, and characteristics of marketed drugs.

Firms usually begin the process of obtaining a nonproprietary name by filing a submission with the USAN Program or the WHO when a drug is in phase I or phase II clinical trials. Most prefer to complete generic name assignments by the time they are ready to publish papers about the drug so that they can use the name instead of a manufacturer code in publications. The USAN must be assigned before conducting premarketing labeling negotiations with the FDA.

Conclusions
For decades, assignment of a USAN has been a key step in the development and marketing of a new active pharmaceutical ingredient, because a substance cannot be marketed in the United States without a name. The primary goals of the USAN Council are to facilitate the safe use of medications by assigning names that are unlikely to result in medical errors and to ensure that drug names are reflective of what physicians, pharmacists, and patients need to know about each substance. The USAN can affect how payers, health care professionals, patients, and the investment community perceive a drug—and therefore patients’ access to drugs.

https://journalofethics.ama-assn.org/article/how-do-drugs-get-named/2019-08