The former vice presidEnt of American Therapeutics Inc. has pleaded guilty to making a false statement to the U.S. Food and Drug Administration to gain approval of a generic drug prescribed for children.
Sanyasi R. Kalidindi, 39, of Piscataway, N.J., entered the plea yesterday to Judge John R. Hargrove in U.S. District Court in Baltimore.
Prosecutor Raymond A. Bonner said Kalidindi and other American Therapeutics employees reported false manufacturing data to the FDA concerning the antibiotic erythromycin, and later fabricated documents to mislead FDA investigators who came to check the company's manufacturing records.
American Therapeutics' erythromycin did not meet the FDA's manufacturing standards, Bonner said, and the company later changed its formula for the drug without telling the FDA.
Bonner said Kalidindi also engaged in "other criminal activities, including other misrepresentations to the FDA," but the prosecutor declined to enumerate them until the defend
ant's sentencing hearing next Feb. 10.
American Therapeutics, of Bohemia, N.Y., has figured prominently in a Baltimore-based federal probe of the generic drug industry that has lasted more than three years.
Raju V. Vegesna, the company's founder and former president, pleaded guilty last year to two racketeering charges connected to bribes he paid to FDA officials to gain quick approvals of generic drugs for public sale.
Vegesna has been a fugitive since last October, when he fled to his native India to avoid serving a two-year prison term. His no-parole sentence was the harshest imposed on any of nearly 20 individual defendants convicted so far in the investigation.