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Published on 10/31/2005 in the Prospect News Biotech Daily.

AstraZeneca's Zactima receives FDA orphan drug designation

By Angela McDaniels

Seattle, Oct. 31 - AstraZeneca said that the U.S. Food and Drug Administration has granted orphan drug designation to its drug Zactima for the treatment of patients with rare forms of thyroid cancer.

AstraZeneca said it has also applied for orphan drug designation for Zactima in Europe for the treatment of medullary thyroid cancer.

Zactima is being developed in a phase-2 clinical trial for the treatment of medullary thyroid cancer and phase-3 clinical trials in advanced non-small cell lung cancer are scheduled to start in the next few months, the company said.

The orphan drug designation was designed to promote the development of products that demonstrate promise for the treatment of rare diseases or conditions, specifically, those that affect less than 200,000 people in the United States, the company said.

AstraZeneca is a drug manufacturer based in London.


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