FDA Brand Name Approval: What the Updated Proprietary Name Review Procedure Means for Pharmaceutical Companies

A pharmaceutical brand name is not accepted by the U.S. Food and Drug Administration simply because it is distinctive, memorable or available as a trademark. In the United States, a proposed proprietary name is evaluated as part of the product’s medication-safety and regulatory review.

FDA’s updated MAPP 6720.2 Rev. 2, effective August 8, 2024, explains how the Center for Drug Evaluation and Research handles name-review requests submitted under INDs, NDAs, BLAs, supplements and ANDAs. The update reinforces an important point: proprietary name review is a coordinated regulatory process, not a final branding check shortly before launch.

The process is led by the Office of Surveillance and Epidemiology. Within OSE, the Divisions of Medication Error Prevention and Analysis assess the proposed name from a safety perspective. For prescription products, the Office of Prescription Drug Promotion considers whether the name could create promotional or misbranding concerns.

Other CDER functions, including the Office of New Drugs or Office of Generic Drugs, may also contribute.

FDA then consolidates these viewpoints and communicates whether the name is conditionally acceptable or not acceptable. This is not a separate, unconditional “approval” of the brand name. Final use remains linked to the marketing application and the product characteristics ultimately approved.

Timing the FDA Submission

Timing is therefore a strategic consideration. FDA’s performance goal is to communicate a decision within 180 days for a proprietary name submitted during IND development and within 90 days for a name submitted with an NDA or BLA, or as part of a supplemental application.

These timelines depend on FDA receiving a complete submission. Missing or unclear information can delay the assessment and may cause the proprietary name review clock to be stopped.

What Does FDA Actually Test?

A proprietary name review published in 2025 illustrates the depth of the assessment. DMEPA used FDA’s Phonetic and Orthographic Computer Analysis, or POCA, system to identify potentially similar drug names. It also conducted prescription-simulation studies involving healthcare professionals.

The proposed name was tested in written inpatient orders, outpatient prescriptions, verbal orders and computerized provider order entry. The assessment did not examine spelling and pronunciation in isolation. FDA also considered factors such as strength, dose, dosage form, route of administration and frequency of use when determining whether name confusion could plausibly result in a medication error.

This means that a high degree of name similarity does not always lead automatically to rejection, just as a relatively low similarity score does not guarantee acceptance. The practical question is whether confusion is reasonably foreseeable under the conditions in which the medicine will be prescribed, dispensed and administered.

Start Preparing Early

For pharmaceutical companies, the implication is clear: regulatory name safety should be built into the naming process from the beginning. Trademark clearance and linguistic screening remain essential, but they should be combined with look-alike and sound-alike analysis, prescription simulation and an assessment of product-specific risk factors.

Companies should also maintain credible alternate names and be prepared to resubmit a proposed name if relevant product characteristics change before approval. In the 2025 FDA review, conditional acceptability was explicitly linked to the product characteristics described in the submission.

A strong pharmaceutical name must therefore do more than support positioning. It must remain clear, distinguishable and safe throughout the medication-use process. Preparing for FDA review early can reduce the risk of late-stage non-acceptance, protect launch timelines and help avoid the significant cost of emergency renaming.

Written by Michael Dijkstra Taurel

of Readge pharma naming