Cardura Advisory Cmte. To Discuss Limiting Hypertension Use To Second-Line
Executive Summary
FDA's Cardiovascular & Renal Drugs Advisory Committee is expected to discuss limiting Pfizer's Cardura (doxazosin) to second-line treatment for hypertension May 24.
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Pfizer Cardura Potential Labeling Changes Should Await More Data - Cmte.
Any potential changes to Pfizer's antihypertensive therapy Cardura (doxazosin) labeling should await additional data from NIH's ALLHAT study, FDA's Cardiovascular & Renal Drugs Advisory Committee said May 24.
Pfizer Cardura Potential Labeling Changes Should Await More Data - Cmte.
Any potential changes to Pfizer's antihypertensive therapy Cardura (doxazosin) labeling should await additional data from NIH's ALLHAT study, FDA's Cardiovascular & Renal Drugs Advisory Committee said May 24.
Scios Natrecor
Cardiovascular & Renal Drugs Advisory Committee will discuss nesiritide for treatment of acute congestive heart failure May 25. Scios will present data from the 498-patient Vasodilation in the Management of Acute Congestive heart failure trial begun in October 1999. FDA found the agent "non-approvable" and requested further study in April 1999. Scios submitted the amended NDA Jan. 10. The meeting will be held at the National Institutes of Health Masur Auditorium in Bethesda, Md. beginning at 9 a.m. The committee will review Pfizer's Cardura (doxazosin) May 24 beginning at 8:30 a.m. (1"The Pink Sheet" April 9, p. 31)