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Andrx’ ANDAs on hold

This article was originally published in The Tan Sheet

Executive Summary

FDA has placed Andrx in "Official Action Indicated" status, thus placing all of the firm's abbreviated new drug applications are on hold, the company announces Sept. 6. The action followed an FDA inspection of Andrx' manufacturing facilities that ended in May 2005 and resulted in the issuance of a "Form 483." The company says it had responded to FDA, and included a proposed corrective action plan in its response. The agency has not yet commented on either the response or the corrective action plan, the company said. According to its second-quarter 10-Q filing Andrx has approximately 30 ANDAs pending at FDA...





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