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Pfizer’s Cardura

Executive Summary

Is "approvable." FDA issued a letter to the company Aug. 8, stating that Cardura (doxazosin) could be approved as a once-daily treatment for hypertension. The NDA for Cardura was filed in March 1987. Cardura received FDA's Cardio-Renal Drugs Advisory Committee's recommendation for approval in May 1989. The committee determined that doxazosin was comparable to other antihypertensives such as atenolol, nadolol and metoprolol when patients were in a standing position. They found that the drug was somewhat less effective in patients in the supine position ("The Pink Sheet" May 8, 1989, p. 6). Cardura will be marketed by Pfizer's Roerig division.



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