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Armstrong albuterol ANDA suitability petition

Executive Summary

Armstrong Pharmaceuticals 200 mcg albuterol sulfate dry powder multi-dose inhaler contested by Schering-Plough in an Oct. 29 letter to FDA. In the letter, Schering claims that the Armstrong system "is an entirely new drug delivery system" not comparable to the referenced product Rotohaler marketed by Glaxo division Allen & Hanbury's. Schering contends that the Armstrong inhaler should undergo adequate and well-controlled investigations to establish its safety and efficacy.
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