Pfizer Norvasc Advisory Committee Review Cancelled
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Cardiovascular & Renal Drugs Advisory Committee was slated to review additional indications for amlodipine based on the ALLHAT study at an April 5 meeting. User fee deadline for the sNDAs is in June.
You may also be interested in...
Pfizer To Present ALLHAT Analysis At Advisory Committee On Antihypertensive Labeling
The company will present a non-inferiority analysis suggesting Norvasc (amlodipine) is similar to the diuretic chlorthalidone in preventing hypertension outcomes during a June 15 meeting of FDA's Cardiovascular & Renal Drugs Advisory Committee, the agency says.
Pfizer To Present ALLHAT Analysis At Advisory Committee On Antihypertensive Labeling
The company will present a non-inferiority analysis suggesting Norvasc (amlodipine) is similar to the diuretic chlorthalidone in preventing hypertension outcomes during a June 15 meeting of FDA's Cardiovascular & Renal Drugs Advisory Committee, the agency says.
Pfizer Norvasc Goes Before Advisory Cmte. April 5 For Review Of ALLHAT Supplement
FDA's Cardio-Renal Advisory Committee will review supplemental indications for reduction of risk of fatal coronary heart disease, non-fatal myocardial infarction and stroke.