The FDA is ordering PrimaPharm to stop advertisements of its drug Hydase, saying that the ads are misleading because the company fails to communicate risks associated with the product.
The agency's Division of Drug Marketing, Advertising and Communications (DDMAC) wrote in its June 29 letter that the company's incomplete advertisement for Hydase (hyaluronidase injection) violates the Federal Food, Drug, and Cosmetic Act. The agency is ordering PrimaPharm to "immediately cease" the use of this ad. DDMAC also wants the company to provide a comprehensive plan of action for disseminating a more accurate ad. The agency wants a response to the letter by July 14.
"The sales aids raise public health and safety concerns through their complete omission of risk information for Hydase by suggesting Hydase is safer than has been demonstrated," the letter said. The materials are supposed to include the warnings in the FDA-approved product labeling, stating that the drug should not be injected into or around an infected or acutely inflamed area, should not be used to reduce the swelling of bites or stings and should not be applied directly to the cornea.
Hydase is an adjuvant, used to increase the absorption and dispersion of other injected drugs, to improve resorption of radiopaque agents, and for hypodermclysis.
PrimaPharm did not respond to a request for comment by presstime.
