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Executive Summary

BRISTOL-MYERS' PRECEF (CEFORANIDE) INJECTION WILL BE LAUNCHED IN SEPTEMBER, the firm said following FDA approval of the drug May 24 for twice-a-day I.M. and I.V. administration. The semisynthetic broad spectrum cephalosporin will be available in 500 mg, 1 gm and 2 gm vials; 500 mg, 1 gm and 2 gm piggyback containers; and 10 gm and 20 gm hospital bulk containers. Bristol-Myers filed the original NDA for Precef in December of 1980. The drug was given a therapeutic classification of 1C by FDA -- signifying a new molecular entity with little or no therapeutic gain. According to FDA-approved labeling, Precef is indicated for the treatment of serious bone and joint infections, endocarditis, lower respiratory tract infections, bacterial septicemia and skin and skin suture infections caused by Staphylococcus aureus. In addition, lower respiratory infections caused by Streptococcus pneumoniae, Klebsiella pneumoniae and Haemophilius influenza may also be treated with Precef, as may bacterial septicemia caused by Streptococcus pneumoniae and E. coli. Proteus mirabilis, Klebsiella pneumoniae and E. coli infections of the urinary tract and skin and skin sutures are also indicated for treatment with the drug, with the additional indication of Staphylococcus epidermis infections of skin and skin sutures. Precef is the second cephalosporin NDA to be approved by the agency during the week. SK&F's Monocid once-daily injectable product was also cleared by FDA The prophylactic use of Precef preoperatively is indicated "in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated, e.g., vaginal hysterectomy." Labeling states that "the perioperative use of Precef may also be effective in surgical patients in whom infections at the operative site would present a serious risk, e.g. during prostetic arthroplasty and open-heart surgery." FDA's Anti-Infective Drugs Advisory Cmte. debated Precef's prophylaxis claim at its January meeting ("The Pink Sheet" Feb. 6, T&G-3).

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