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Tamper-Resistant PSE Takes Big Pharma Stage: Bayer Licenses Acura’s Formulation

This article was originally published in The Tan Sheet

Executive Summary

Bayer gains exclusive worldwide license to Acura Pharmaceuticals’ Impede technology for use in a pseudoephedrine-containing product resistant to extraction to make methamphetamine. The deal is Acura’s first licensing, and the first move toward tamper-resistant PSE by a major pharma firm.

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Perrigo Recalls Tamper-Resistant PSE Product Due To Contamination

FDA on Dec. 21 identified the recall as class II, for violative products that may cause temporary or medically reversible adverse health consequences though the probability of serious consequences is remote. Perrigo acquired the Zephrex-D brand and rights to the formulation in 2016.

Perrigo Recalls Tamper-Resistant PSE Product Due To Contamination

FDA on Dec. 21 identified the recall as class II, for violative products that may cause temporary or medically reversible adverse health consequences though the probability of serious consequences is remote. Perrigo acquired the Zephrex-D brand and rights to the formulation in 2016.

Indiana Ups State Power To Limit Pseudoephedrine Product Sales

DEA has the authority and expertise to conduct stress tests on pseudoephedrine formulations, says CHPA state government director Carol Gutierrez. But Indiana allows its pharmacy board to say whether a PSE product is tamper-resistant.

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