Promotional Materials for Lumigan False, Misleading, FDA Tells Allergan

The Food and Drug Administration has told Allergan Inc. that a direct mailer for Lumigan (bimatoprost ophthalmic solution) is false or misleading because it makes unsubstantiated superiority claims about the drug, according to an “untitled” letter posted Dec. 6 on FDA’s website.

Lumigan is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension, FDA said.

The direct mailer implies that treatment with Lumigan is superior to treatment with the competing drug product latanoprost in that Lumigan will be effective after latanoprost stops working or when latanoprost no longer is effective in adequately ...