Hi-Tech Pharmacal to comply with FDA on diabetes meds

Hi-Tech Pharmacal of Amityville said July 24,

Hi-Tech Pharmacal of Amityville said July 24, 2013, that it had received a federal warning about three of its medicinal creams for diabetics. (Credit: Steve Pfost, 2012)

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Hi-Tech Pharmacal Co. said Wednesday it would comply with a federal warning about three of its over-the-counter creams advertised to diabetics.

A top executive of the Amityville-based manufacturer of generic and brand-name drugs told Newsday it would remove "diabetic" from two product names, along with other wording changes on labels, accompanying descriptions and selling materials.

The federal Food and Drug Administration, in a July 15 letter, warned Hi-Tech that "claims" on the labels and other materials about the creams' beneficial effect on some symptoms of diabetes make them new drugs subject to federal approval. The agency said it hadn't received applications seeking such approval.

Without federal go-ahead, the FDA said, the three creams cannot be sold.

The creams are Diabeti-Derm Antifungal Cream and Zostrix Diabetic Foot Pain Relief Cream and Diabetic Joint & Arthritis Pain Relief Cream.

Together, they generated $1.1 million in sales for the fiscal year ended April 30. Hi-Tech's total sales in the same year were $232 million.

"What we need to do there is just change the label a little bit," Hi-Tech chief financial officer William Peters said. "We're going to comply with what we've been requested to do . . . as soon as possible."

The company has three weeks to present a remedy to the FDA. Peters said the plan so far doesn't call for removing the creams from retailers' shelves.

He also said the active ingredients in the creams "aren't new . . . they're used in a lot of other products. The FDA has already agreed that these products can be sold as OTC products."

Hi-Tech's announcement came before Wednesday's stock market opening. Company shares closed down 66 cents, or nearly 2 percent, to $35.92 in Nasdaq trading.

Hi-Tech was among 15 companies and online retailers accused Tuesday by the FDA of marketing illegal treatments for diabetes.

Agency commissioner Dr. Margaret Hamburg said, "Consumers who buy violative products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management."

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