Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Life Healthcare Communications

Life is a creative communications agency offering multi-channel solutions for the healthcare industry. We use a storytelling approach to turn...

Latest intelligence

Unlocking the potential of science and technology in the UK
Greater collaboration is vital in post-Brexit UK, says Alderley Park leader...
NHS regional footprints
What to expect from 2019...
Not another weight-loss ad
Christmas is over and the gyms are packed, it’s a never-ending tale. But why do we do it to ourselves every year?...

Infographics