Company Under Investigation, Officials Confirm
WASHINGTON (AP) _ Bolar Pharmaceutical Co. Inc. is under criminal investigation for allegedly submitting false information to the Food and Drug Administration about two generic drugs, officials confirmed Thursday.
The inspector general at the Department of Health and Human Services is conducting a criminal investigation concerning Bolar’s versions of Dyazide, a high-blood pressure drug, and Macrodantin, used to treat urinary tract infections, said Judy Holtz, a spokeswoman for the office.
The company allegedly switched its product for the original drug in product safety tests and submitted the results to the FDA to win approval for its drug.
Holtz said the inspector general is also investigating another alleged product-switching by Bolar involving an anti-psychotic generic drug it was developing in 1982. This version of thioridazine was never marketed.
The inspector general’s office has discussed the investigation with the U.S. attorney’s office in Baltimore, she said.
The FDA also has been investigating the product-switching allegations involving the three drugs.
Bolar has agreed to recall from wholesalers its 100-milligram capsules of nitrofurantoin because of the questions raised by the FDA. The brand-name version of this drug is Macrodantin, made by Norwich-Eaton Pharmaceuticals.
The FDA also wants to remove Bolar’s version of Dyazide from the market.