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Executive Summary

MERCK's VASOTEC (ENALAPRIL) APPROVED FOR PREVENTION OF CHF and "decreas[ing] the incidence of hospitalization" in "clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction [</=] 35%)," approved labeling states. The indication for SNDA 18-998/S-032 was submitted July 10, 1992 and amended Oct. 18, 1993, and has been "approvable" at FDA since Aug. 16. Merck received the supplemental NDA approval on Nov. 4. The prevention of congestive heart failure indication was recommended for approval by FDA's Cardiovascular & Renal Drugs Advisory Committee on Feb. 19 ("The Pink Sheet" Feb. 23, p. 20). The recommendation was based on the results of the prevention arm of the Studies of Left Ventricular Dysfunction (SOLVD), which were reported in November 1992. FDA's approval letter notes that for the first six months, advertising and promotional materials for Vasotec 2.5, 5, 10 and 20 mg tablets for the new indication "should include a description of the patient population studied. In addition," the letter directs, "please include the third and fourth paragraphs of the Clinical Pharmacology, Heart Failure, Mortality Trials subsection in toto." Vasotec is already approved for treatment of symptomatic CHF based on the SOLVD treatment arm, as well as for the treatment of hypertension. Most recently, Bristol-Myers Squibb's Capoten (captopril) received the prevention of CHF indication in stable LVD patients post-MI on Sept. 23 ("The Pink Sheet" Oct. 4, T&G-4). It also had received the advisory committee recommendation at the same February meeting.

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