Sinusitis Drug Suffers FDA Jolt

A company named Replidyne wanted to get fast track approval for its faropenem medoxomil drug but suffered a shock when FDA said that the company should further conduct tests for the drug rather than getting it approved in a fast track manner. This drug can be used in treating pneumonia, sinusitis, chronic bronchitis and other types of skin infections. FDA wants an exhaustive study to be conducted and termed the study conducted by the company to be insufficient for getting approval. The company was hopeful that it would easily get the approval of FDA. The probable reason was that FDA has changed its requirements since it started the approval process and now wants companies to prove that their drug is not only effective but superior to the alternatives available in the market. I believe that it a correct move by FDA because a number of drugs are being developed under the umbrella of biotechnology and most of them have not been able to meet the expectations. It seems FDA wants to play safe.

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