FDA warns Bioniche on Sotradecol misbranding

(Reuters) - U.S. health regulators issued a warning letter to Bioniche Life Sciences Inc for publishing "false or misleading" information on Sotradecol, its drug to treat varicose veins.

Certain web pages of Bioniche and distributor AngioDynamics Inc present efficacy claims for Sotradecol but fail to communicate any information about the risks associated with the product, the U.S. Food and Drug Administration (FDA) said in a letter to the company.

The web pages also broaden the approved indication for Sotradecol and overstate its efficacy, the FDA added.

The FDA said it is very concerned by the company's continued violative promotion of this product. Bioniche was cited for the same violations in a letter in April 2006, it said.

The agency also warned that failure to correct the violations may result in regulatory action, including seizure or injunction, without further notice.

Shares of Bioniche were up 2 percent at 48 Canadian cents Tuesday on the Toronto Stock Exchange.

(Reporting by R. Manikandan in Bangalore; Editing by Unnikrishnan Nair)