New USAN Application Policy Effective March 15, 2007
Current labeling requirements in the United States require that a USAN be obtained for the form of the compound that is to be marketed. Often this has necessitated filing a USAN application for the parent compound, followed by a separate USAN application for the modified (salt) form at a later date. To streamline the application process and ensure compliance with current and future FDA and INN policies, USAN applications have been revised and are located under the section "application forms." There are now 5 separate application forms:
Form A is used when requesting a USAN for the modified (salt) form of a new compound (for which no USAN exists) to be marketed in the United States. Applicants will receive two separate USAN(s); one for the parent and one for the salt form intended for marketing.
Please note that because the USAN Program required naming only the form of the compound to be marketed in the United States, and the INN Program names only the active parent, a USAN and INN were often different. To maintain consistency and avoid FDA approval delays if a related substance is later marketed, the USAN Program now requires filing Form A to obtain USAN(s) for the salt and base forms of the compound. The fee associated with this application is $18,500.
Form B is used to request a USAN for a single entity (active moiety, parent compound) for which no modified or salt form will be developed or marketed in the United States. The fee associated with this application is $12,500.
Form C is used to request a USAN for the modified (salt) form of a compound for which a USAN already exists. If a manufacturer finds that they have not requested a USAN for a salt to be marketed, or if they decide to market a different salt than what was named by the USAN Council, they are requested to pursue a USAN for the new salt form using Form C. The fee associated with this application is $6,000.
Form D is used to request a revision to published, adopted USAN. The fee associated with this application is $3,000.
Form E is used to request a USAN for contact lens materials. The fee associated with USAN for new contact lens materials is $12,500. The USANM fee is $6,000 and the USANR fee is $3,000. (Form E is also used to request both USANM and USANR for contact lenses.)
The USAN Program expects that this revised application procedure will simplify the process of obtaining the multiple USAN(s) required for salts and parent forms of compounds and better international harmonization of non-proprietary names.