USANs and Clinical Development

I was mailed about how USANs/INNs fit into the drug development process. There is an excellent and detailed overview on the AMA website, and I've taken the liberty of reproducing some of the most salient points here (however, the preceeding link and the content therein is the definitive source!). The other terms you'll often see in this sort of area are JAN and BAN (which are Japanese Approved Name and British Approved Name respectively), BANs with the exception of adrenaline/epinephrine are the same as INNs now.

  • Preclinical
    • Drug studies conducted in vitro and in animal models
    • Planned trade names may be filed, if known, with the United States Patent and Trademark Office (USPTO) and other trademark offices
    • Data about the mechanism of action and potential safety problems that could derail marketing are gathered
  • IND
    • Firm obtains permission to conduct clinical studies in the United States (US) from the FDA and receives an IND number
  • Phase 1
    • Small-scale safety studies conducted in healthy volunteers
    • Earliest time that US firms may request a United States Adopted Name (USAN), or non-US firms may request an International Nonproprietary Name (INN)
  • Phase 2
    • Small-scale efficacy studies in patients
    • Typical time for US firms to apply for a USAN
    • Ballots sent to USAN Council (USANC) for review
    • When firm and USANC reach consensus, USAN Program files to obtain an INN on behalf of the firm
    • Planned trade names may be filed for review by FDA, along with supporting documentation
  • Phase 3
    • Large-scale efficacy and safety studies in humans
    • Many firms publish results of earlier clinical and preclinical studies and want the USAN at this time
    • USAN usually adopted and published
    • Non-US firms with an INN obtain USAN status for this name
  • New Drug Application (NDA) or Biologics Licensing Application (BLA)
    • Firm requests clearance from the FDA to market the drug
    • USAN required for packaging and labeling negotiations, promotional materials
    • USP adds nomenclature information pertaining to dosage forms and delivery methods
    • Firm receives final approval of trade name from the FDA

Thanks to xkcd for the cartoon above...