Regulatory Focus™ > News Articles > FDA: Confusion Between Similar-Sounding Product Names Causes Injury

FDA: Confusion Between Similar-Sounding Product Names Causes Injury

Posted 29 December 2011 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has had guidance regarding complete submissions for evaluating proprietary names for quite some time.  Regulations mandate that the FDA must review and approve any proposed proprietary name before the product can be approved.

This review does not take in to account unapproved products that come in to the market after the innovator.  This has led to a mix-up between an FDA-approved eye medicine called Durezol (difluprednate ophthalmic emulsion) and an unapproved prescription topical wart remover called Durasal (salicylic acid).

The FDA is reporting that a "serious injury" occurred when the two were accidentally mixed-up, and has urged pharmacists to be "vigilant" when filling prescriptions for Durezol.

Durezol was approved by the FDA before Duresol was first marketed, so the FDA did not find any issues with the proprietary name for Durezol.

The maker of Duresol, Elorac, Inc, has not responded to FDA's requests to remove the product from the market or responded to requests for comments from Reuters.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.