Antihypertensive Cardio Labeling Should Be Applied To New Classes – Cmte.
Executive Summary
Class labeling for reduction of cardiovascular outcomes based on blood pressure lowering should be applied to new classes of antihypertensives, members of FDA's Cardiovascular & Renal Drugs Advisory Committee said
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Hypertension Class Labeling Does Not Release Sponsors From Large Trials
FDA should ensure that manufacturers do not construe the addition of outcomes claims to antihypertensive drug labels as lowering the approval standards for future hypertension agents, members of FDA's Cardiovascular & Renal Drugs Advisory Committee emphasized during an April 26 meeting
Hypertension Class Labeling Does Not Release Sponsors From Large Trials
FDA should ensure that manufacturers do not construe the addition of outcomes claims to antihypertensive drug labels as lowering the approval standards for future hypertension agents, members of FDA's Cardiovascular & Renal Drugs Advisory Committee emphasized during an April 26 meeting
Antihypertensive class labeling
FDA's draft language for antihypertensive drug class labeling on cardiovascular outcomes claims will be considered by its Cardiovascular & Renal Drugs Advisory Committee on April 26. The committee proposed class labeling on improvement in cardiovascular outcomes from blood pressure reduction in June 2005 (1"The Pink Sheet" June 27, 2005, p. 8). The meeting, which will be held at the Hilton in Gaithersburg, Md. beginning at 8 a.m., will also address a meta-analysis of antihypertensive drug placebo-controlled trials. [Editor's note: To 2watch a webcastor order a video/DVD of this, or any other meeting, visit FDAAdvisoryCommittee.com.]...