January 3rd, 2014
FDA cites Dara BioSciences for misleading marketing of Soltamox
By David Bracken
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.” T
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.