Pfizer Norvasc Patent Term Extension Keeps AmVaz Off The Market Until 2007
This article was originally published in The Pink Sheet Daily
A federal appeals court rules the extended patent protection applies to all salts of amlodipine, including the maleate salt used in Dr. Reddy's antihypertensive agent.
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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
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.
Real-World Evidence: CDC Prioritizing Populations, Outcomes For COVID-19 Vaccine Effectiveness Studies
Strategy for assessing how the earliest vaccines to reach market perform beyond clinical trials includes leveraging existing surveillance and data platforms, and employing a diversity of study approaches, CDC epidemiologist says; high-priority areas for study include protection against symptomatic illness among health care workers and prevention of severe disease in the elderly.