Abbott Laboratories gets FDA not-approvable letter for Xinlay drug application

By Jennifer Chiou

New York, Oct. 14 - Abbott Laboratories announced it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for its new drug application for Xinlay (atrasentan), according to an 8-K filing with the Securities and Exchange Commission.

The company filed the application for Xinlay, an oral drug for metastatic hormone-refractory prostate cancer to lessen bone pain, in December 2004

The FDA's Oncologic Drugs Advisory Committee did not recommend approval in September.

Despite the FDA decision, the company is continuing a Phase III study to be completed in 2006 for Xinlay. The company previously said it may advance the drug for other cancers, including kidney, ovarian, bran and non-small-cell lung cancers.

The decision does not affect the ongoing trial M00-244, which is evaluating Xinlay in patients with non-metastic hormone-refractory prostate cancer.

Based in Abbott Park, Ill., the health care company discovers, develops and markets products for its three segments: pharmaceutical, diagnostic and ross products, which include pediatric and adult nutritionals.

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