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news.Theravance, a biopharmaceutical company, has submitted a new drug application to the FDA for telavancin to treat nosocomial pneumonia caused by gram-positive bacteria such as methicillin-resistant Staphylococcus aureus.
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Telavancin is a bactericidal, once-daily injectable investigational antibiotic with a multifunctional mechanism of action.
Telavancin was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA), and other gram-positive bacteria.
Rick Winningham, CEO of Theravance, said: “The submission of the telavancin new drug application (NDA) for hospital-acquired pneumonia (HAP) is another important milestone for the telavancin program. We look forward to working closely with the FDA on their review of our HAP NDA submission.”