Hi-Tech Pharmacal gets FDA warning on diabetes meds

Hi-Tech Pharmacal Co. said Wednesday it would comply with a federal warning about three of its medicinal creams for diabetics.

The Amityville-based manufacturer of generic and brand-name drugs said it had received a "warning letter" from the federal Food and Drug Administration on July 15. The letter "related to certain statements that appear in labeling" on the creams, the company said.

In the letter, the FDA said Hi-Tech's claims about the creams make them drugs subject to FDA approval, which has not been granted.

The FDA said sale of the creams across state lines was prohibited without first receiving federal approval.

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

The three generated $1.1 million in sales for the fiscal year ended April 30. Hi-Tech's total sales for the year were $232 million.

Hi-Tech is one of 15 companies accused by the FDA Tuesday of marketing illegal treatments for diabetes. In announcing the nationwide crackdown, the FDA said, "consumers should exercise caution before using products claiming to be herbal or all-natural alternatives to FDA-approved prescription drugs. These products should be considered unsafe and should not be used."

Hi-Tech made its announcement came this morning's stock market's opening. In early trading, Hi-Tech shares were down 43 cents, or more than 1 percent, to $36.15.

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Title : Hi-Tech Pharmacal gets FDA warning on diabetes meds
Published on : Thursday, July 25, 2013
Category : Diabetes
Post URL : http://internal-med.blogspot.com/2013/07/hi.html