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Fast Track Designation Granted To Drug By FDA

Added October 20th, 2006

The Food and Drug Administration has granted what is known as fast track designation to a next-generation antifolate PDX (pralatrexate), which is a unique treatment for patients suffering from T-cell lymphoma, and is manufactured by Allos Therapeutics, Inc. The announcement was made by the company, and officials stated that they were very pleased with the FDA’s decision.

Paul L. Berns, President and Chief Executive Officer stated: "We are extremely pleased that the FDA has recognized the urgent and unmet medical need for effective new therapies for the treatment of patients with T- cell lymphoma.”

He added: "Fast track designation represents a significant regulatory milestone in the development of PDX, and further validates the potential of PDX in this patient population."

The fast track program is used by the FDA to prioritize the review of certain medications, which are through to be able to fill gaps in the medical market in terms of treatment, and which are designed to treat life-threatening or serious diseases.

Fast Track Designation... | Printable Version (Opens In New Window)

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