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FDA: Travatan ads ‘misleading’
WASHINGTON — A popular glaucoma drug’s promotional material has been deemed misleading by the Food and Drug Administration, according to a letter sent to the drug’s marketer.
Alcon’s Travatan (travoprost) is indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP-lowering medications. The FDA’s Division of Drug Marketing, Advertising and Communications has determined a flash card Alcon uses in its marketing is “false or misleading because it fails to reveal material facts, presents unsubstantiated superiority claims, broadens the indication, minimizes risks and presents dosing claims that are unsubstantiated and inconsistent with the approved product labeling.”
The group told Alcon the flash card misbrands the drug by suggesting Travatan is safer or more effective than has been demonstrated and encourages use in circumstances other than those in which Travatan has been shown to be safe and effective.
Alcon has until Oct. 6 to respond to the letter.
Earlier this year, the FDA cited Allergan for misleading promotional material for its glaucoma medication Lumigan (bimatoprost). Allergan had until Sept. 20 to issue a written response to the false advertising claims.