CombinatoRx and Neuromed Pharmaceuticals announced that the FDA has issued Neuromed a letter extending its review of the New Drug Application for the product candidate Exalgo extended-release tablets by three months. The extended Prescription Drug User Fee Act date for the FDA to complete its review of the Exalgo NDA has been set for February 22, 2010. The FDA stated in its letter extending the PDUFA date that the purpose for the extension is to allow the FDA more time for a full review of Neuromed’s submission, including a recent amendment by Neuromed to the Exalgo NDA. :theflyonthewall.com
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