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New Delivery System for RELISTOR in Pre-Filled Syringes Submitted for U.S. and European Marketing Approval
Wyeth, 08/06/09
Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth, announced submission of a supplemental New Drug Application to the United States Food and Drug Administration and an Extension Application to the European Union European Medicines Agency for RELISTOR subcutaneous injection for a new delivery system, pre–filled syringes. RELISTOR was approved last year in single–use vials. RELISTOR is indicated for the treatment of opioid–induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. If approved, pre–filled syringes of RELISTOR are expected to be available in the U.S. and Europe as early as the first half of 2010.
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