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| |  FDA Approves Zyvox (Linezolid) For Gram-Positive Infections PEAPACK, NJ -- April 18, 2000 -- The U.S. Food and Drug Administration (FDA) approved Zyvox(TM) (linezolid injection, tablets, and for oral suspension, Pharmacia Corporation) for the treatment of patients with infections caused by Gram-positive bacteria. With IV and oral formulations, Zyvox comes from the first completely new class of antibiotics to reach hospitals in 35 years. The FDA approval follows the recommendations made on March 24, 2000 by the FDA Anti-Infective Drugs Advisory Committee. Zyvox is indicated for adults in the treatment of nosocomial (i.e. hospital-acquired) pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections and vancomycin-resistant Enterococcus (VRE) infections caused by indicated bacteria. These indications also include approval for use in: - complicated skin infections caused by methicillin-resistant Staphylococcus aureus (MRSA); Gram-positive bacteria are currently defined by many in the public health and infectious disease communities as one of the greatest challenges in hospital infections. Clinical studies involving more than 4,000 patients, treated primarily in the hospital, have shown that Zyvox is effective in treating infections caused by Gram-positive bacteria, including some that are resistant to other antibiotics. "Zyvox has a profile that makes it truly unique. It represents an important discovery in the treatment of Gram-positive infections," said Robert Moellering, MD, Professor of Medicine, Harvard Medical School. "The ability to continue patients on Zyvox tablets following therapy with Zyvox IV gives dosing flexibility to physicians and provides convenience to patients as well as other potential benefits such as completing therapy at home." Zyvox is available in IV and oral formulations. Zyvox tablets are 100 percent bioavailable, meaning physicians can use the IV and tablet forms interchangeably without making a dose adjustment. The ability to complete treatment with an oral formulation may help enable some patients to leave the hospital sooner. "Zyvox will be a vital alternative for the treatment of the rising number of Gram-positive infections seen in hospitals worldwide," said Goran Ando, MD, Executive Vice President and President, Research & Development, Pharmacia Corporation. "We are proud our researchers recognized the need for a new class of antibiotics well before this medical challenge existed." Zyvox comes from a new class of antibiotics, the oxazolidinones. Zyvox attacks bacteria by stopping protein production at a very early point in the process that is different from any other antibiotic. Without protein production, bacteria cannot multiply and bacteria die. Zyvox is generally well tolerated. The adverse events reported for patients receiving Zyvox and comparators in clinical trials were similar. The most common events for patients treated with Zyvox were diarrhea (8.3 percent), headache (6.5 percent), nausea (6.2 percent) and vomiting (3.7 percent). Events were usually mild to moderate in intensity and limited in duration. Certain patients should have periodic monitoring of their blood platelet levels while taking Zyvox. Zyvox is being developed for global use. As part of a European filing strategy, a market authorization application was submitted to the UK Medicines Control Agency in November 1999. Applications are also being submitted throughout Asia and Latin America. Pharmacia Corporation is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn with Monsanto Company and its G.D. Searle unit. Pharmacia has a broad product portfolio, a robust pipeline of new medicines, and an annual investment of more than $2 billion in pharmaceutical research and development. In its Monsanto subsidiary, Pharmacia has one of the world's leading fully integrated agricultural businesses. Related Links: Zyvox (linezolid) and Pharmacia Corporation.
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