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PFIZER RECEIVES CLEARANCE TO MARKET NEW BROAD-SPECTRUM ANTIBIOTIC TROVAN
Approval Follows Largest Clinical Program in Pfizer History
New York, Dec. 19 -- Pfizer Inc said today its broad-spectrum antibiotic Trovan (trovafloxacin) has gained marketing clearance from the U.S. Food and Drug Administration.
Discovered and developed by Pfizer, Trovan was cleared for the treatment of 14 bacterial infections, which is the largest number of indications ever included at an initial drug approval in the United States.
More than 13,000 patients participated in 87 studies involving Trovan and 30 comparator regimens, representing the largest clinical trial program in Pfizer history.
Ã¬Trovan is an important milestone in PfizerÃs long history of discovering and developing medicines that fight infectious disease,Ã® said William C. Steere, Jr., chairman and chief executive officer. Ã¬The magnitude of research behind Trovan attests to PfizerÃs commitment to bringing innovative therapies to doctors and patients.Ã®
It is expected that Trovan, in many cases, may allow doctors to replace complex combinations of antibiotics with a single, simple treatment.
A member of the quinolone class of antibiotics, Trovan is effective against four important bacterial groups: Gram-negative, Gram-positive, atypical and anaerobic bacteria. Trovan is available in both oral and intravenous formulations and can be administered with once-a-day dosing.
Trovan works by disrupting the DNA involved in bacterial replications. The drug is rapidly absorbed and widely distributed throughout the body. The most common side effects are dizziness, nausea, headache and lightheadedness.
The New Drug Application submitted to the FDA for Trovan was the largest the agencyÃs anti-infectives division has ever received. Trovan will be available by prescription in February.
Trovan was approved for use in adults with acute bacterial exacerbations of chronic bronchitis, acute sinusitis, community-acquired pneumonia, nosocomial (hospital-acquired) pneumonia, complicated intra-abdominal infections, gynecologic and pelvic infections, uncomplicated urinary tract infections, chronic bacterial prostatis, pelvic inflammatory disease, chlamydial cervicitis, gonorrhea, uncomplicated skin and skin structure infections including diabetic foot, and surgical prophylaxis. Trovan is the first and only antibiotic ever approved for oral prophylactic use in surgery.
Pfizer Inc is a research-based health care company with global operations. In 1996 the company reported sales of more than $11 billion and, in 1997, anticipated spending more than $1.9 billion on research and development.
Full prescribing information for Trovan is available upon request.