Trovan Approved by FDA!
Friday December 19, 10:29 am Eastern Time
Company Press Release
SOURCE: Pfizer Inc.
Pfizer Receives Clearance To Market New Broad-Spectrum Antibiotic
Trovan; Approval Follows Largest Clinical Program In Pfizer History
NEW YORK, Dec. 19 /PRNewswire/ -- Pfizer Inc (NYSE: PFE - news) 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 drug regimens, representing the largest clinical trial
program in Pfizer history.
''Trovan is an important milestone in Pfizer's long history of
discovering and developing medicines that fight infectious diseases,''
said William C. Steere, Jr., chairman and chief executive officer. ''The
magnitude of research behind Trovan attests to Pfizer's commitment to
bringing innovative therapies to doctors and patients.''
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 replication.
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 Pfizer submitted to the FDA for Trovan was the
largest the agency's anti-infectives division has ever received. Trovan
will be available by prescription by 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 prostatitis, pelvic inflammatory
disease, chlamydial cervicitis, gonorrhea, uncomplicated skin and skin
structure infections, complicated skin and skin structure infections
including diabetic foot, and surgical prophylaxis. Trovan is the first
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, anticipates spending more than $1.9 billion on research
and development.
SOURCE: Pfizer Inc. |
