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FDA rejects Replidyne antibiotic

Replidyne submitted a new drug application in December 2005 for four indications including acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin

Somaxon insomnia drug demonstrates efficacy

Results demonstrated that 6mg of Silenor was effective at inducing sleep and maintaining sleep throughout the night. There was a measured improvement of sleep time of 51 minutes

FDA requires more research to approve birth drug

The approvable letter also outlined post-approval clinical requirements, which are consistent with recommendations made by the FDA advisory committee in August 2006. “We will request a meeting with