Progenics Pharmaceuticals, Inc. and Wyeth Announce FDA Has Accepted For Filing the New Drug Application for Subcutaneous Methylnaltrexone

TARRYTOWN, N.Y., & COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) has accepted the file for review of Progenics’ New Drug Application (NDA) 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 subcutaneous methylnaltrexone.

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