Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: Meretek petition

This article was originally published in The Gray Sheet

Executive Summary

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...
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT009783

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel