Former ATI exec Daphne Pai
Ex-American Therapeutics, Inc. VP-regulatory affairs and quality control pleads guilty July 16 in Baltimore federal court to submitting false information to FDA in ANDA application for thiothixene 20 mg caps. ATI, which received sales of over $8 mil. for the antipsychotic, withdrew its thiothixene applications in January 1991 after an FDA inspection discovered fraudulent information in the ANDAs. According to a Justice Department release, Pai misrepresented the number of caps made and amount of ingredients used to produce an R&D lot of thiothixene. Pai faces a maximum of five year imprisonment and a $250,000 fine.
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