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Generic Pediatric Labeling, ANDA Review Times To Be Addressed By OGD

This article was originally published in The Tan Sheet

Executive Summary

Situations in which different private label manufacturers are first to make paragraph IV certifications against separate patents covering the same drug is an issue of increasing importance for FDA's Office of Generic Drugs

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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

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