Approvals In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering-Plough Asmanex approved after seven years: Asmanex (mometasone furoate) will not debut before autumn due to ongoing manufacturing validation, Schering-Plough says. The drug clears FDA March 30 for "the maintenance of treatment of asthma as prophylactic therapy in patients 12 years of age and older and treatment of asthma patients who require oral corticosteroid therapy, where adding Asmanex Twisthaler therapy may reduce or eliminate the need for oral corticosteroids." Schering already markets mometasone in the allergy inhaler Nasonex and in the topical cream Elocon. The Asmanex NDA, submitted in November 1998, was delayed by good manufacturing practice compliance issues...
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September 2010 Approvals
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