FDA WARNING_LETTER - Aurora Pharmaceutical, Inc. - March 11, 2025

The FDA issued a Warning Letter to Aurora Pharmaceutical on February 7, 2025, regarding false or misleading promotional communications for their FDA-approved products: Altren® (altrenogest), SwineMate® (altrenogest), and Barrier™ for dogs (imidacloprid and moxidectin). The FDA reviewed the company website and linked webpages, identifying violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) sections 502(a), 502(n), 201(n), and 21 CFR 202.1(e)(5), which constitute misbranding.

The core issue is the omission or downplaying of serious safety warnings in promotional materials. For Altren® and SwineMate®, which have significant human user safety risks (e.g., skin absorption leading to menstrual cycle disruption or prolonged pregnancy, requiring specific glove types), the website and product sheets prominently feature benefits while omitting or presenting risk information in a less prominent, smaller font, or on a separate page, lacking fair balance. Print advertisements for Altren® also omit crucial human safety warnings or present them in an unreadable font.

For Barrier™ for dogs, the website omits the boxed warning regarding oral exposure in dogs and topical exposure in children, as well as other animal and human safety information. The product sheet for Barrier™ for dogs also lacks fair balance, with extensive benefit information preceding a