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NDA Accepted for Progenics, Wyeth OIC Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has accepted for review an NDA from Progenics Pharmaceuticals and Wyeth for subcutaneous methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 30, 2008, to complete its review of the NDA. The companies also announced that the European Medicines Agency (EMEA) has validated for review Wyeth’s Marketing Authorization Application (MAA) for the treatment. ...

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