Replidyne and Forest End Collaboration on Faropenem
I hadn’t commented on the fact that Replidyne and Forest Labs had ended their agreement for development of Faropenem.
StockHouse.com : Replidyne and Forest End Faropenem Collaboration:Zoom structure
This means Replidyne now has full rights to the drug in the US for adults and pediatric use. However, they must overcome the non-approvable letter they received back in Oct 2006 from the FDA. The FDA wanted to see additional clinical trials of a superiority design for acute bacterial sinusitis (ABS) and acute exacerbation of chronic bronchitis (AECB). There were no safety or chemistry and manufacturing concerns. BTW, this drug has been approved in Japan since 1997.
For those interested, here is the structure.
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Technorati Tags: antibiotics, Faropenem, Replidyne
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