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Schering-Plough

Executive Summary

Submits comments to FDA on an acetaminophen/pseudoephedrine/chlorpheniramine ANDA suitability petition filed by the Washington, D.C. law firm Kleinfeld, Kaplan and Becker. Schering maintains that the petition should be denied because the proposed formulation is "considerably different" than that of the reference product Drixoral Plus. The antihistamine in Drixoral Plus is dexbropheniramine maleate 3 mg, whereas the antihistamine in the proposed product is chlorpheniramine maleate 6 mg, Schering said. The firm contends that the petitioner's drug is "a new drug," since there is no listed product to which the proposed product, particularly the chlorpheniramine component, can be compared....
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PS014665

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