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US FDA asks for more info on J&J's Doribax

 
• By Tom Moberly

The US FDAhas told Johnson & Johnsonthat it will require additional information before approving the intravenous antibiotic Doribax (doripenem) for the additional use of treating hospital-acquired pneumonia, including ventilator-associated pneumonia (VAP).

The US FDAhas told Johnson & Johnsonthat it will require additional information before approving the intravenous antibiotic Doribax (doripenem) for the additional use of treating hospital-acquired pneumonia, including ventilator-associated pneumonia (VAP).

The FDA outlined the actions it required in a complete response letter to the company. J&J told Scrip that it...

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More from Focus On Asia

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