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FDA rejects Adventrx’s lung cancer drug Exelbine

Adventrx receives rejection from the FDA for its new non-small cell lung cancer drug, Exelbine, over authenticity issues

The US Food and Drug Administration (FDA) has rejected Adventrx Pharmaceuticals' New Drug Application (NDA) for Exelbine, a drug for the treatment of non-small cell lung cancer. Exelbine is a reformulated version of Pierre Fabre Pharmaceuticals' Navelbine.

This rejection from the FDA has caused shares in Adventrx Pharmaceuticals to plunge as much as 61 per cent.

In the complete response letter that Adventrx received, the FDA decided that it could not approve the Exelbine NDA in its present form as the “authenticity of the drug products used in the pivotal bioequivalence trial could not be verified, which placed the results of the trial into question”. It stated that this trial would have to be repeated in order to address the problem.

Adventrx is planning to request a meeting with the FDA to discuss the FDA's response to the application which contradicts the views of Adventrx, which believes that the authenticity of the drug products are verifiable.

11th August 2011

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