FDA Approves Levaquin Short-Course Therapy Treatment
RARITAN, N.J. The Food and Drug Administration has approved the use of the five-day treatment regimen for people who suffer from urinary tract infections and acute pyelonephritis.
The approval is based on the results of a double blind, randomized clinical trial. Ortho-McNeil, creator of Levaquin, tested the stronger dosage of its oral treatment on more than 1,000 patients. Both treatment groups demonstrated the resolution of, or improvement in, urinary symptoms with the drug’s stronger dosage (750 mg/once daily/five days).
“The availability of this high-dose, short-course antibiotic regimen provides clinicians with an important tool in the management of cUTI andu of the David Geffen School of Medicine at UCLA. “Patients do not always finish a longer course of antibiotics. A shorter course of antibiotics offers patients the convenience of five day, once-daily therapy.”
Each year, urinary tract infections account for more than eight million physician visits in the U.S., according to statistics. Furthermore, it is estimated that more than 250,000 Americans suffer from AP every year, with 10 to 30 percent of cases resulting in hospitalization.
Levaquin, which was introduced to the market in 1996, is used to treat bacterial infections caused by susceptible pathogens. Aside from treating urinary tract infections and acute pyelonephritis, Levaquin has also been used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, two forms of pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infections (mild to moderate), and more.
GSK flu vaccine facility in Quebec is nearly completed
QUEBEC CITY, Canada GlaxoSmithKline said that it is near completion of its Quebec City manufacturing facility, used to develop the company’s influenza vaccine.
After a two-year—and $199 million—investment to upgrade the manufacturing site, the location will increase the capacity of vaccine doses to 75 million per year, the company said. The expansion has also given way to providing this facility, and existing ones, new equipment and other innovative technologies to assure efficient production.
The company has also doubled the size of its vaccine workforce in Quebec City since January 2006.
“[This] announcement reinforces the key role that both Quebec and Canada play in GSK’s global vaccine business,” said Michel Baijot, vice president of Worldwide Strategic Alliances and Business Development, GlaxoSmithKline Biologicals, the company’s vaccine division. “Through this investment, Quebec and Canada will have an impact on global health by supporting countries in their influenza pandemic planning.”
According to GSK, the company supplies about 75% of the Canadian government’s seasonal flu vaccine purchases and will also provide Canada with a pandemic vaccine in the event of an influenza pandemic.
FDARA attempt to limit citizens petitions not likely to have much effect, expert claims
WASHINGTON According to Richard Silver, senior vice president of Equity Research for Lehman Brothers, the Food and Drug Administration’s Revitalization Act, which included language intended to limit the use of citizen petitions to block approvals of generic drugs, will not stop their use by brand companies, the FDA reported.
“Citizen’s petitions … we do not think they’re going to go away. The backlog continues to grow,” Silver said last week during the Generic Pharmaceutical Association’s Annual Policy Conference in Washington, D.C. “We don’t think the citizen’s reforms will change the behavior of brand companies significantly.”
Two versions of the legislation are currently pending before a conference committee.