FDA Hits Imprimis Rx With Warning Letter Over Promotional Materials

The FDA issued a warning letter to San Diego, Calif.-based Imprimis Rx over promotional materials for its compounded glaucoma drug Pred-Moxi-Brom (prednisolone, moxifloxacin, bromfenac).

The company claims that the product is a compound based on FDA-approved products. However, the agency said these claims are problematic because the FDA understands the company uses bulk drug substances that are not FDA-approved.

The FDA also took issue with the company’s claims that its Pred-Moxi-Brom product is superior to other FDA-approved products. The agency also cited the company for making unsupported claims that the product leads to better patient compliance and treatment outcomes. The FDA couldn’t find any data supporting these claims.

Read the warning letter here: bit.ly/3ztZZwk.