Rating of Generic Drug Downgraded
WASHINGTON — The Food and Drug Administration on Thursday formally downgraded its rating of a generic drug made by Bolar Pharmaceutical Co. for treating high blood pressure, saying it is not equivalent to Dyazide, the brand-name product.
By changing the code it assigns Bolar’s product, the FDA is telling physicians that it does not consider the generic drug to have the same therapeutic value as the brand-name drug.
The FDA had announced plans for the change on Aug. 28, when it also began moving to withdraw the generic from the market because of questions about whether it has the same effect as Dyazide. The removal process is still under way.
In a letter to Copiague, N.Y.-based Bolar, Carl C. Peck, director of the FDA’s Center for Drug Evaluation and Research, said that “significant questions remain as to the reliability†of the data the company submitted to the FDA as part of safety and effectiveness tests conducted last year.
