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Drug Name Development Timeline and USAN Review Procedure

Drug name development timeline

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

Postmarketing

  • USAN required to market the drug in the US
  • Continued safety data on the drug and names are collected
  • Changes to generic or trade name require large-scale education of health care professionals, approval from the FDA
  • USP publishes monographs determining drug standards, titled with the USAN  

USAN review procedure

Application and initial review

  • Firm gathers required supporting information, including documentation of a search to verify proposed names are free of trademark and generic name conflicts
  • Pharmaceutical manufacturer or sponsor submits a completed application
  • USAN Program staff verifies chemistry, searches databases for drug information
  • Staff determines how the drug may be classified using the nomenclature scheme and whether the proposed names appropriately reflect its action
  • Staff reviews names for conflicts with generic or proprietary names
  • Staff prepares a ballot with the firm's proposed names and alternative suggestions, if any
  • Conflicts with generic or trade names are noted for the USANC

USANC balloting

  • USANC members review names and make selections
  • Scientists and physicians on the USANC represent the American Medical Association (AMA), American Pharmacists Association (APhA), United States Pharmacopeia (USP) and the FDA
  • Review criteria include absence of conflicts with trade or generic names, appropriate use of the nomenclature scheme, usefulness of the proposed names to the health care providers
  • Names too similar to existing generic or trade names are rejected
  • FDA opinion on the proposed name(s) is sought through the FDA representative to the USANC
  • When consensus is reached, staff forwards the name selection to the firm

Review of the USANC's suggestion by the firm

  • Firm reviews the USANC's selection and accepts or rejects it
  • Suggested name is posted for public comment online
  • If the firm accepts the name, it proceeds through international review before adoption as a USAN
  • Firms rejecting a name must supply alternatives and the rationale for rejection, with supporting documentation
  • Rejection leads to another round of review by USAN Program staff and the USANC

International review and clearance

  • To ensure international harmonization, USAN Program staff requests an INN
  • The INN Experts review and accept the proposed name, or suggest an alternative
  • INN review criteria include conflicts with non-US trademarks or generic names, connotations in languages other than English, and comformity to international nomenclature schemes
  • INN Expert Group comprised of scientists and regulatory experts from around the world

Review of the INN decision by the firm and USANC

  • Firm and USANC notified of the INN Expert Group's decision by the USAN Program staff
  • Firm and USANC may accept or reject the INN Expert Group's alternative suggestions, if any

Adoption and publication

  • Occurs after the USANC, firm and INN Experts reach a consensus
  • Adopted USAN are published online and forwarded to Chemical Abstracts Service (CAS) and the USP
  • Internationally, names are published twice, as proposed INN and recommended INN