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