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Schering-Plough Reports Garenoxacin (T-3811) NDA accepted for FDA review
|February 13, 2006.|
February 13, 2006, Tokyo; Toyama Chemical Co., Ltd. (President and CEO: Katsuhiko Nakano) announced today that the U.S. Food and Drug Administration has accepted for review its New Drug Application (NDA) for garenoxacin submitted in the U.S. by Schering-Plough Corporation (Chairman and CEO: Fred Hassan). Schering-Plough plans to file a similar new drug application for garenoxacin with the European Medicines Agency (EMEA) this year.
T-3811 (generic name: garenoxacin) is a new-type quinolone antibacterial agent discovered by Toyama Chemical. Toyama Chemical and Schering Plough entered into a license agreement to develop, use and sell garenoxacin worldwide except Japan, South Korea and China in June, 2004.
Different from conventional quinolone antibiotics, T-3811 (garenoxacin) is a new type of quinolone antibacterial agent with no fluorine atom at position 6 of the quinolone skeleton. T-3811 has a broad spectrum of activity, especially against resistant strains of Gram positive organisms such as MDRSP (Multi Drug Resistant Streptococcus Pnemonia) and MRSA (Methicillin-Resistant Staphylococcus Aureus), which are growing concerns in the medical community.
In clinical studies carried out abroad, the efficacy of T-3811 has been confirmed in a wide range of infections from respiratory tract infections to surgical infections and T-3811 shows a good safety profile compared to the comparative drugs. T-3811 is expected to contribute to performance of Toyama Chemical greatly after its launch.
In Japan, all clinical studies necessary to file a new drug application in Japan have been completed, and Toyama Chemical is currently preparing for its submission in the 1st half of this year.
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