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Executive Summary

Miles' Cipro (ciprofloxacin HCl) is the first member of the new quinolone class of antibacterial agents to be approved by FDA with a broad spectrum of indications. The drug was approved Oct. 22; the NDA was submitted in February 1986. Approved labeling states that Cipro is indicated for lower respiratory, skin and skin structure, bone and joint, and urinary tract infections caused by susceptible gram positive and gram negative organisms. Cipro is also indicated for infectious diarrhea. The only other marketed quinolone in the U.S., Merck's Noroxin (norfloxacin), has one approved indication for urinary tract infections. Miles will begin contacting the trade on Nov. 6. Average wholesale prices for Cipro, supplied in bottles of 50 tablets, are: $84.03, for 250 mg tabs; $90.04, for 500 mg tabs; and $174.07, for 750 mg tabs. The product is also supplied in unit dose packages of 100 tabs, which sell for slightly more than twice the bottle prices. To date, the company's only announcement of the approval of Cipro has been to hospital pharmacists and clinical investigators involved in the compassionate use IND for the antibacterial. Miles said that it began notifying clinical investigators participating in its Cipro compassionate use IND the week of Oct. 26 so that orders could be placed for patients on waiting lists for the product. According to the company, over 2,000 patients have received the antibacterial under the compassionate use protocol. Cipro is currently approved for use in West Germany, the U.K., and the Philippines. Cipro was approved by FDA as a 1B drug, designating a new molecular entity with a modest therapeutic gain over existing therapies. Cipro marks Miles first new molecular entity (NME) to clear the agency since 1982 when three of the company's NMEs were approved by FDA -- the antischistosomal Biltricide, the anthelmintic Niclocide, and the anesthetic Amidate. At least two other oral quinolone antibacterials are nearing approval at FDA -- Sterling's Eradacil (rosoxacin) for gonorrhea, and Warner Lambert's Comprecin (enoxacin). Warner-Lambert's product is also a broad-spectrum antibacterial. The NDA filing seeks indications for skin, genital, urinary, and upper and lower respiratory tract infections. Although Miles hasn't had many NME approvals in recent years, it launched its Aldalat brand of nifedipine in January 1986. The calcium channel blocker has been comarketed by Pfizer under license from Bayer A. G. Miles currently has at least three products pending at FDA: the topical antifungal Mycospor (bifonazole) and the calcium channel blockers Baypress (nitrendipine) and Nimotop (nimodipine). Baypress will be comarketed by Roche.

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