FDA cites Dara BioSciences for misleading marketing of Soltamox

01/03/2014 1:26 PM

01/03/2014 1:28 PM

Federal regulators have cited Raleigh-based Dara BioSciences for running misleading sales ads for Soltamox, an oral liquid formulation used in the treatment and prevention of breast cancer.

In a letter dated Dec. 20, Food and Drug Administration officials said the company’s marketing “omits material facts, contains unsubstantiated superiority claims, and omits important risk information for Soltamox.”

The FDA has asked Dara to immediately cease misbranding Soltamox and submit a written response to the agency by Jan. 7 about how it intends to comply with the request.

Dara is in danger of getting removed from the Nasdaq exchange unless it can raise its share price above $1. Dara’s stock closed Friday at 61 cents, up 2 cents.

The company has filed plans for a reverse stock split to boost its stock price and avoid delisting.

“We believe that challenges lie ahead for Dara and that these must be addressed by Dara management without the distraction of a potential Nasdaq delisting to divert our focus and efforts,” the company’s CEO, David Drutz, wrote in a letter to stockholders last month.

Dara has three products on the market, including Soltamox. Bionect is a topical treatment for skin irritation and burns caused by radiation. Dara also has exclusive U.S. commercial rights to market and sell Gelclair for the treatment of oral mucositis, or swelling and bleeding of the mouth and gums.

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