Glaxo's pricing of the second-generation oral cephalosporin Ceftin (cefuroxime) will be the same as Lilly's Ceclor (cefaclor) on a cost-per-day basis, Glaxo said. Glaxo predicted a late February launch for Ceftin, which cleared FDA on Dec. 28. The twice-a-day product will compete directly with Lilly's first-generation cephalosporins Ceclor and Keflex (cephalexin), which must be taken four times daily. Ceftin also carries labeling that allows for easy pediatric dosing. Roche will comarket Ceftin with Glaxo. The arrangement builds on earlier collaborations with Zinacef, the injectable formulation of cefuroxime, and the anti-ulcer drug Zantac (ranitidine). The oral product will be promoted by Glaxo's entire 1,180-rep detail force, along with 220 reps from Roche. Approved labeling notes that Ceftin is indicated for the treatment of: pharyngitis and tonsillitis; otitis media; lower respiratory tract infections; urinary tract infections; and skin and skin structure infections. In addition, Ceftin is "highly stable to bacterial beta-lactamases, especially plasmidmediated enzymes that are commonly found in Enterobacteriaceae," the product's labeling notes. FDA review of the product took 2-1/2 years; the Ceftin NDA was submitted in July 1985. The U.S. oral cephalosporin market continues to grow. For example, prescription audit firm Pharmaceutical Data Services reported that in 1986 U.S. retail sales of Ceclor were $150 mil. at pharmacy acquisition cost. That figure represented an annual growth of 21% over the previous year. Ceclor has continued to show good growth in 1987, making up for declining sales of Keflex due to generic competition. Lilly is expected to attempt to market its own oral version of cefuroxime, under a 1969 cephalosporin licensing agreement with Glaxo. Lilly has piggybacked ANDAs on to Glaxo's U.S. product approvals several times in recent years, including approvals in 1986 for I.V. cefuroxime under the brand name Kefurox, and in 1985 for I.V. ceftazidime (Glaxo's Fortaz) under the Tazidime brand. In anticipation of Ceftin's approval, Glaxo has been running "available soon" ads in medical journals since the summer. Ceftin will be available in 125, 250 and 500 mg tablets in bottles of 20s and 60s. The antibiotic will also be packaged in 100-tablet, unit-dose packs of 125 or 250 mg and 50-tablet packs of 500 mg. Under information for pediatric patients, the labeling states: "During clinical trials, the tablet was well tolerated by children who could swallow the tablet whole. Children who cannot swallow the tablet whole may have the tablet crushed and mixed with food." GLAXO's CEFTIN (CEFUROXIME AXETIL) TABLETS The box below is a reproduction of the indication section of Ceftin's approved package insert. INDICATIONS AND USAGE: CEFTIN (cefuroxime axetil, Glaxo) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1. Pharyngitis and Tonsillitis caused by S pyogenes (group A beta-hemolytic streptococci). (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. CEFTIN is generally effective in the eradication of streptococci from the oropharynx. CEFTIN is not indicated for the prophylaxis of subsequent reheumatic fever because data to support such use are not yet available.) 2. Otitis Media caused by S pneumoniae, H influenzae (ampicillin-susceptible strains), B catarrhalis (ampicillin-susceptible strains), and S pyogenes (group A beta-hemolytic streptococci). 3. Lower Respiratory Tract Infections (bronchitis) caused by S pneumoniae, H influenzae (ampicillin-susceptible strains), H parainfluenzae (ampicillin-susceptible strains). 4. Urinary Tract infections caused by E coli and K pneumoniae in the absence of urological complications. 5. Skin and Skin Structure Infections caused by S aureus and S pyogenes (group A beta-hemolytic streptococci). Bacteriological studies to determine the causative organisms and its susceptibility to cefuroxime should be performed. Therapy may be started while awaiting the results of these studies. Once these results become available, antibiotic treatment should be adjusted accordingly.
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