FDA slams SuperGen statements

FDA on Friday issued a warning to consumers and healthcare practitioners about what the agency characterized as "misrepresentations" in a SUPG press release about the approval of Mitozytrex mitomycin. The compound is a generic version of chemotherapy agent Mutamycin from Bristol-Myers (BMY). Mitozytrex uses SUPG delivery technology and is used to treat adenocarcinomas of the stomach and pancreas. The November 2002 SUPG press release "exaggerates the efficacy of Mitozytrex and fails to include the significant risks associated with the use of the drug," according to FDA. "Indeed, the press release does not even mention acute adverse reactions that can result from administration of Mitozytrex, which include fever, anorexia, nausea, and vomiting. The press release also fails to disclose that Mitozytrex is associated with more serious adverse events, such as myelosuppression and hemolytic uremic syndrome," the agency added.

FDA also slammed SUPG's claims that its product is a "supergeneric," or enhanced version of the brand name drug. The agency said there is no data to support SUPG's claims that the safety, efficacy, pharmacokinetic or storage characteristics of Mitozytrex differ from those of Mutamycin. ...