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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

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QUOTED. 25 November 2020. Ricki Chase.

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