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SK&F's MONOCID ONCE-A-DAY CEPHALOSPORIN IS "APPROVABLE"

Executive Summary

SK&F's MONOCID ONCE-A-DAY CEPHALOSPORIN IS "APPROVABLE" the company announced in a May 16 press release. SK&F said approval is "expected within a month" pending finalization of product labeling. Monocid (cefonicid) joins SK&F's Cefizox, which was launched in September, and Ancef as the company's third major injectable cephalosporin. An NDA for Monocid was filed in July 1982. Monocid will be the first once-a-day cephalosporin to reach the market. Emphasizing the cost advantages of its once-daily product, SK&F cited a study by John Eisenberg, MD, et al, which assessed the cost of preparing and administering cephalosporins at four hospitals in Philadelphia and quantified savings that would be made from replacement of current cephalosporin use with Monocid. The "average potential savings in materials and labor" with the use of Monocid "was $5.40 per patient day of therapy," SK&F said, while "the average potential annual savings was $103,000 per hospital." "Depending on the degree of replacement of similar products with Monocid, savings could reach $277 mil. per year at the 75% replacement level," SK&F stated. SK&F noted that future research for new anti-infectives will take two approaches. Short-term, the company will develop "fourth-generation cephalosporins with wider spectra and better safety profiles, and new classes of antibiotics where a single product may supplant multiple-drug therapy." The company will also seek improvements in dosage forms and delivery systems. In the long-term, SK&F said research will focus on developing new products and therapies "for conditions such as chronic prostatitis, otitis media and chronic urinary tract infections."

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