FDAnews Drug Daily Bulletin

Allergan’s journal ad for its ketorolac tromethamine ophthalmic solution Acular LS “is false or misleading” and suggests that the product “is effective for an entirely new use,” according to a warning letter from the FDA’s Division of Drug Marketing, Advertising and Communications.

The warning letter, sent May 25 to Allergan President and CEO David Pyott and posted to the agency’s website recently, states that the ad misbrands Acular LS because it “broadens the indication, presents unsubstantiated superiority claims and omits important risk information.”

The ad presents data intended to show a favorable result in a study of patients undergoing phacoemulsification who received either Acular LS or Nevanac (nepafenac ophthalmic suspension), the agency said. However, “Acular LS is not approved for any use in patients undergoing phacoemulsification. … The inclusion below these statements of the approved indication for Acular LS does not mitigate this misleading presentation,” the warning letter said.

Moreover, the data presented “do not constitute substantial evidence or substantial clinical experience supporting use in patients undergoing phacoemulsification,” the warning letter said.

The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6376c.htm.