FDA Targets Generic Drug: The Food and...

FDA Targets Generic Drug: The Food and Drug Administration said it plans to withdraw Bolar Pharmaceutical Co.’s approval to sell a generic drug used to treat urinary tract infections, and it wants the company to withdraw the product from drugstores. In a letter to the Copiague, N.Y.-based company, the FDA said tests on samples of Bolar’s drug and the brand-name drug “strongly suggest that Norwich-Eaton’s Macrodantin product was substituted for Bolar’s product” in tests required for FDA approval. The FDA is also moving to change its listing of Bolar’s version of Macrodantin, generically called nitrofurantoin, to indicate to physicians that the agency does not consider the product to be therapeutically equivalent to the brand-name drug.