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

Alimenterics

This article was originally published in The Gray Sheet

Executive Summary

New drug application for the firm's 13C urea-based solution included in the Pylori-Chek test kit is undergoing FDA review despite a four-year exclusivity clause granted by FDA to Meretek for its Pranactin combination device/drug system for detection of H.pylori infection in the digestive system, Alimenterics says. On March 13, Meretek filed a petition with FDA requesting a stay of approval of all pending NDAs for 13C urea-based H.pylori tests because it had gained exclusivity from the agency. In an April 7 response to the petition, Alimenterics asserts that the Pylori-Chek is not subject to the exclusivity clause "because the NDA submitted by Alimenterics was a 'full' NDA." Meretek's Sept. 17 Pranactin approval was supported by an abbreviated NDA, Alimenterics explains. In addition to the 13C urea-solution, the Pylori-Chek consists of the 510(k)-cleared LARA non-radioactive carbon urea breath test and a breath collector device. "The Gray Sheet" (March 23, In Brief) incorrectly stated that the LARA breath test is a radioactive carbon urea test

You may also be interested in...



Oxford/AZ’s COVID-19 Vaccine Cuts Virus Spread By 60%

Oxford University/AstraZeneca’s COVID-19 vaccine cuts the spread of the virus by 60%, apart from having 70% efficacy in reducing infections in vaccinated individuals. While that is good news for their Indian partner, Serum Institute, the 90% efficacy shown in a subset due to a dosing error causes a dilemma.

GemVax Aims For Alzheimer’s 'Game Changer' As Phase III Approaches

After announcing positive topline Phase II results for its Alzheimer’s candidate late last year, Korea's GemVax releases additional data showing significant improvement in secondary outcomes, further raising expectations for the novel peptide drug.

QUOTED. 25 November 2020. Ricki Chase.

The US FDA’s decision to ask on device adverse event reports whether the device involved had been serviced by a third party could help the agency as well as device makers, says Ricki Chase, compliance practice director at Lachman Consultant Services.

UsernamePublicRestriction

Register

OM013626

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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