American Therapeutics ANDA fraud

Executive Summary

FDA informs ATI in a March 26 letter that it is planning to withdraw approval of the company's danazol ANDA and in the meantime downgrade the product's rating in the "Orange Book" from "AB" to "BX." The agency said that it is initiating the action because of "untrue statements of material fact" found in a review of the ANDA. Earlier, FDA said that it has suspected ATI of falsifying its records for danazol to hide the use of an active ingredient from an unapproved source ("The Pink Sheet" Dec. 24, p. 5). ATI's danazol is the only approved generic version of Winthrop's Danocrine, an androgen used to treat endometriosis. The danazol ANDA was approved in December 1987. ATI was fined $ 1 mil. in October 1990 for making illegal payments to a former FDA review chemist during 1987 and falsifying documents for several other ANDAs....