FDA is eying new policy on Rx names.
SILVER SPRINGS, Md. -- The Food and Drug Administration is seeking public comment on plans that would enable pharmaceutical firms to reserve proprietary names for medicines as early as the end of Phase II trials.
The regulatory agency has established a public docket in the Federal Register in response to drug manufacturers' concerns of rival companies taking their planned names while their drugs are still in development.
In recent years, the FDA has judged drug names as part of the drug labelling approval process and thus does not finalize this authorization until the final marketing application has been approved.
Until then, review of a proprietary name "is limited to a tentative acceptance of that name," said the FDA. "It is possible that a name judged tentatively acceptable may later be found unacceptable for a number of reasons."
The deadline for comments in the Federal Register is October 27.