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FDA approves anti-itching drops

FDA approves anti-itching drops

Following a previous AP story, the AP (6/27) reported that on Friday, June 26, the seven experts in the Food and Drug Administration's ophthalmic panel voted unanimously that Bepreve [bepotastine besilate], "an anti-itching drug from eye-care company Ista Pharmaceuticals, is safe and effective." The panel's vote "amounts to a recommendation for approval. Although the FDA is not required to follow the group's advice, it usually does."

 

Dow Jones Newswires (6/27, Favole) explained that "ISTA wants FDA approval to market Bepreve to people with conjunctivitis, or pink eye, caused by allergies." According to FDA officials, "the agency found no serious side effects with Bepreve. The most common side effect was a distorted sense of taste after getting the drops, which was reported in 20 percent of patients."

 

Reuters (6/27, Richwine) noted that if the FDA gives final approval to Bepreve, the drug would be available by prescription only.