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Theravance says FDA delays new Vitabiv decision74 days ago
(AP:SOUTH SAN FRANCISCO, Calif.) Theravance Inc. said Friday the Food and Drug Administration delayed a decision on whether to approve its infection drug Vitabiv as a treatment for hospital-acquired pneumonia.
In a complete response letter, the FDA asked for more data and analysis on patients who participated in clinical trials of Vitabiv, Theravance said. If that information does not resolve the FDA's questions, Theravance said it might have to conduct new studies to gain approval.
The FDA wants more information about deaths in Theravance's clinical studies, comparing patients on Vitabiv to those on other treatments, as well as details on why Theravance combined data from two trials. It also wants a pediatric drug development plan and a safety update, Theravance said.
Vitabiv, or telavancin, was approved in September as a treatment for complicated skin infections like MRSA. Theravance and its partner Astellas Pharma launched the drug Nov. 5.
In afternoon trading, Theravance shares were unchanged at $13.13.
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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