Atacand Superiority Claim Versus Cozaar Clears FDA With Dosing Caveat
Executive Summary
AstraZeneca Atacand antihypertensive superiority labeling claim over Merck's Cozaar includes the caveat that the drug's efficacy over twice-daily Cozaar has not yet been studied
You may also be interested in...
Atacand Label May Note 2 mm Hg BP Reduction Over Cozaar, Cmte. Says
AstraZeneca's Atacand labeling may claim a 2 mm Hg reduction in diastolic blood pressure over Merck's Cozaar, FDA's Cardiovascular and Renal Drugs Advisory Committee said July 18
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials