Lumigan is superior to timolol 0.5% dosed twice daily in clinical trials

In particular the FDA warning stated that the promotional letter “lacks fair balance and is misleading because it minimizes important risk information contained in bolded warning in the approved product labeling for Lumigan.” The bolded warning concerns possible permanent changes to pigmented eye tissues, such as increased pigmentation of the iris and periorbital tissue, and increased pigmentation and growth of eyelashes.

The FDA said the letter failed to present this information with prominence and readability comparable to the effectiveness claims. The FDA pointed out that the effectiveness of the drug is talked about in the body of the letter, while the warning is presented in the small print at the end of the letter, after the signature and enclosure reference.buy lumigan cheap may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, lumigan sale usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated.

In the same notice of violation letter, the FDA said it was also troubled by the claim that Lumigan is superior to timolol 0.5% dosed twice daily in clinical trials. The letter stated that the claim was misleading because Allergan was comparing the effectiveness of two products with dissimilar indications. “Timolol is indicated as a first-line therapy whereas Lumigan is indicated as a second-line therapy,” the letter stated. The comparison implies Lumigan is indicated as a first-line therapy, an unapproved indication, the letter stated.