Designation of Official Names and Proper Names for Certain Biological Products
A Proposed Rule by the Food and Drug Administration
FDA is proposing a regulation to designate official names and proper names for certain biological products, following the naming convention outlined in the draft guidance Nonproprietary Naming of Biological Products. The current names and proposed names are shown in the table. As stated in the proposed rule, FDA is seeking action with respect to these six products because of the need to encourage routine use of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices, as well as to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.
|Current Name||Biologics License Application||Proposed Official Name/Proper Name|
|epoetin alfa||103234||epoetin alfa-cgkn|