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GLAXO'S FORTAZ (CEFTAZIDIME) RECIEVED 1-A REVIEW AND CLEARANCE BY FDA

Executive Summary

GLAXO'S FORTAZ (CEFTAZIDIME) RECIEVED 1-A REVIEW AND CLEARANCE BY FDA, indicating that the agency considers the cephalosporin to be a new chemical entity with an important therapeutic gain over other available drugs, Glaxo said in a July 19 press release announcing approval of the drug. In the press release, Glaxo said that Fortaz is "the first injectable antibiotic to receive FDA's highest ranking in over a decade." Among recent cephalosporin approvals, Hoechst Roussel's Claforan (cefotaxime sodium) and Roche's Rocephin (ceftriaxone) have received 1-B approvals from FDA, indicating a new chemical entity and a modest therapeutic advance. SmithKline's Cefizox (ceftizoxime sodium), Glaxo's Zinacef (cefuroxime sodium), Bristol-Myers' Precef (ceforanide) and Pfizer's Cefobid (cefoperazone sodium) all were classified 1-C drugs, indicating new chemical entities with little or no therapeutic advance. The key therapeutic Significance for Fortaz is its effectiveness in treating severe hospital-acquired infections, Glaxo indicated. The firm maintained that it expects Fortaz "to become the drug of choice in treating a wide variety of hospital-acquired infections," which occur in "an average of 5% of patients admitted to general hospitals." Fortaz is indicated for hospital-acquired pneumonias and urinary tract infections, bacterial septicemia and infections in neutropenic cancer patients, Glaxo said. The company said the injectable drug is also "recommended for use in treating lower respiratory tract infections in cystic fibrosis patients who are particularly susceptible to life-threatening pneumonias caused by haemophilus influenzae, staphylococcus aureus and pseudomonas aeruginosa." Fortaz is also indicated "for the treatment of skin and skin structure infections such as burn wound infections, intra-abdominal infections, bone and joint infections and gram-negative meningitis," the firm noted. Glaxo said the drug will be available in early August. Fortaz will be priced "competitive with other third generation cephalosporins," the company stated. Lilly and SmithKline have both claimed marketing rights to Glaxo's cephalosporin under cross-licensing agreements entered into in 1969. SmithKline said it plans to market the drug next year. Lilly also indicated that it would be filing a Form 6 ANDA with FDA to market the drug. Fortaz is already marketed in 11 foreign countries.

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