To streamline the application process and ensure compliance with current and future FDA and International Nonproprietary Names (INN) policies, USAN applications have been revised. There are now 6 separate application forms.

For base and modified forms of a compound

Form A is used when requesting a USAN for the base substance and 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.

Please note that in the past, 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 parent (base) product, 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 $23,000.

Form A: Single entity drug and salt form

For a single entity

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 $15,000.

Form B: Single entity form

For a modified salt form

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 $8,000.

Form C: Modified compound form

Salt form information page

For a revision to an adopted USAN

Form D is used to request a revision to a published, adopted USAN. The fee associated with this application is $5,000.

Form D: Revise established USAN

For contact lens materials

Form E is used to request a USAN for contact lens materials. The fee associated with USAN for new contact lens materials is $15,000. The USANM and USANR fees are $8,000. (Form E is also used to request both USANM and USANR for contact lenses.)

Form E: Contact lens material form

Contact lens material related links

For biologics

Form F is for proteins, peptides, monoclonal antibodies, nucleic acids, all pegylated substances, cell therapies, and gene therapies. Fee for a new monoclonal antibody is $15,000. Fee for a monoclonal antibody for which an adopted USAN already exists is $8,000.

Additional application requirements have been established for biologics. Please review these requirements and include with your application materials.

Biologics application requirements 

Form F: Biologics form

Biologics information pages

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.

(Once the USAN Council initiates the application review, refunds are no longer possible.)

To streamline the application process and ensure compliance with current and future FDA and International Nonproprietary Names (INN) policies, USAN applications have been revised. There are now 6 separate application forms.

For base and modified forms of a compound

Form A is used when requesting a USAN for the base substance and 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.

Please note that in the past, 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 parent (base) product, 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 $23,000.

Form A: Single entity drug and salt form

For a single entity

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 $15,000.

Form B: Single entity form

For a modified salt form

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 $8,000.

Form C: Modified compound form

Salt form information page

For a revision to an adopted USAN

Form D is used to request a revision to a published, adopted USAN. The fee associated with this application is $5,000.

Form D: Revise established USAN

For contact lens materials

Form E is used to request a USAN for contact lens materials. The fee associated with USAN for new contact lens materials is $15,000. The USANM and USANR fees are $8,000. (Form E is also used to request both USANM and USANR for contact lenses.)

Form E: Contact lens material form

Contact lens material related links

For biologics

Form F is for proteins, peptides, monoclonal antibodies, nucleic acids, all pegylated substances, cell therapies, and gene therapies. Fee for a new monoclonal antibody is $15,000. Fee for a monoclonal antibody for which an adopted USAN already exists is $8,000.

Additional application requirements have been established for biologics. Please review these requirements and include with your application materials.

Biologics application requirements 

Form F: Biologics form

Biologics information pages

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.

(Once the USAN Council initiates the application review, refunds are no longer possible.)

Form C: Modified compound form

Form D: Revise established USAN

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