LeuTech gets FDA committee approval

An advisory panel of the FDA last month voted to recommend marketing approval of a Palatin Technologies radiopharmaceutical imaging agent, LeuTech, for diagnosing appendicitis.

Officials of the Princeton, NJ, firm said the FDA’s Medical Imaging Drugs Advisory Committee determined that LeuTech is safe and effective for use in diagnosing appendicitis in patients with uncertain signs and symptoms of the often life-threatening condition.

The panel’s vote merely suggests approval, but the FDA usually follows the recommendations of its advisory panels, Palatin officials said. The company signed a marketing alliance with St. Louis-based Mallinckrodt last year (SCAN 6/6/99). When LeuTech receives final approval, Mallinckrodt will be in charge of marketing and distributing the radiopharmaceutical. Palatin officials had hoped that LeuTech would be available for sale by the middle of this summer.

The agent binds to white blood cells in vivo, which means that LeuTech can be injected and cells labeled without having to draw blood from the patient (SCAN 5/26/99).