Paracelsian calls off launch of dietary supplements with HIV, cancer treatment claims.
This article was originally published in The Tan Sheet
Executive Summary
PARACELSIAN ANDROVIR, ANDROCAR NEAR-TERM COMMERCIALIZATION OPTIONS are being examined by the company after it received a letter from FDA stating that the agency would regard the products as unapproved drugs, the Ithaca, N.Y.-based company announced June 9. "The FDA has made it very clear that the company's plan to market AndroVir and AndroCar as dietary supplements, targeted respectively to the AIDS community and to cancer patients, would cause the FDA to classify these products as drugs, not dietary supplements," Paracelsian said. "Given the FDA's position, we have determined that it would not be economically viable to introduce these products as dietary supplements for the general population."
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning