In Brief: Meretek petition

Meretek petition: March 13 filing seeks stay of all FDA reviews of 13C urea diagnostic products used to detect H. pylori. Document specifically references Alimenteric's LARA radioactive carbon urea breath test, which Meretek contends is similar to the firm's Pranactin combination device/drug system for detection of H. pylori infection in the digestive system. Firm argues that FDA's Sept. 17 approval of a combined 510(k)/new drug application for Pranactin and concurrent granting of four-year marketing exclusivity would be violated if FDA reviewed a similar 13C urea detection product...