Claritin patent extension
This article was originally published in The Tan Sheet
Executive Summary
Schering-Plough's Rx antihistamine's NDA approval was delayed by FDA for two-and-a-half years to gather animal carcinogenicity data, the U.S. General Accounting Office reports Aug. 10. Schering argues the findings strengthen its call for a patent extension due to the extraordinary length of the review - 77.4 months. FDA denies its review took too long, but the company has the support of Senate Judiciary Committee Chairman Orrin Hatch (R-Utah), who has argued any drugs taking more than five years to be approved should be entitled to an extension
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