FDA Takes A Second Look At Dr. Reddy's AmVaz, Will Re-Evaluate Norvasc Competitor
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency stays approval of product, which has a different salt than Pfizer's amlodipine, following questions about the source of data relied upon during review. Dr. Reddy's had been waiting for an appeals court decision on a patent before launching.
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Pfizer Norvasc Patent Term Extension Keeps AmVaz Off The Market Until 2007
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FDA's re-evaluation of the review for Dr. Reddy's AmVaz (amlodipine maleate) should be completed within two months, the agency says in a Feb. 18 court filing