DDMAC deems AzaSite ad misleading

A four-page journal ad for Inspire Pharmaceuticals' AzaSite has been reviewed and determined as misleading by FDA's DDMAC. Regulatory review officer Carole Broadnax, R,Ph, PharmD, issued an untitled letter to Inspire's Kimberly Davis on April 14 saying the ad is deceptive because it “broadens the indication, makes unsubstantiated claims, and omits and minimizes important risks associated with the use of AzaSite,” misbranding the drug in violation of the Federal Food Drug and Cosmetic Act.
While the labeling for AzaSite includes warnings and precautions indicating topical ophthalmic use only, for the treatment of bacterial conjunctivitis, Broadnax claims in her letter that the drug's promotional materials suggest unsubstantiated claims that the drug is more effective than has been demonstrated.
Broadnax writes that the journal ad is unreliable, because it “suggests that AzaSite is indicated to treat any condition that causes ocular surface damage, which could include viral conjunctivitis (pinkeye), chemical injury, blepharitis, dry eye disease, and ocular rosacea, when such has not been demonstrated by substantial evidence or substantial clinical experience.”
DDMAC requested that Inspire immediately cease the dissemination of “violative promotional materials for AzaSite” and provide a written response to the letter by a deadline of April 28. As of press time, reps for Inspire had not returned messages for comments.
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