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Perrigo Liquid Pain Reliever Recall Prompted By Excess Acetaminophen

This article was originally published in The Tan Sheet

Executive Summary

Perrigo is recalling nearly 8,000 bottles of cherry-flavored pain reliever suspension liquid manufactured at its Allegan, Mich. facility.

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Teva's generic equivalent to J&J/Merck's Pepcid AC was approved to carry both heartburn prevention and treatment claims, while Ivax' famotidine 10 mg may only carry prevention claim. A brief in "The Tan Sheet" July 30 incorrectly reported Ivax was the first private labeler approved to carry a prevention claim. According to FDA's Office of Generic Drugs, Teva (which licenses its product to Perrigo) challenged both indications covered by a specific patent, while Ivax challenged a separate prevention indication that was not patent-protected. As a result, Teva's famotidine carries six months of generic exclusivity while Ivax' product does not

Perrigo New Product Launches, PPA Replacements Slated For August

Perrigo expects to offer famotidine Acid Reducer, a generic version of J&J/Merck's Pepcid AC, no later than June, the private labeler told analysts during a conference call May 1.

Perrigo Extended-Release Acetaminophen Launch Delayed By QC Issues

Perrigo has postponed its plans to market private label extended-release acetaminophen until it can resolve quality control issues outlined in a recent FDA warning letter.

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