gonadotropin releasing hormone antagonist, plenaxis, receives us fda approval

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Inpharma 1416 - 6 Dec 2003 The US FDA has approved an injectable suspension of the gonadotropin releasing hormone antagonist, abarelix [Plenaxis; Praecis Pharmaceuticals]. Plenaxis, the first gonadotropin releasing hormone antagonist available as a depot formulation, is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: risk of neurological compromise due to metastases; ureteral or bladder outlet obstruction due to local encroachment or metastatic disease; or severe bone pain from skeletal metastases persisting on narcotic analgesia. Praecis Pharmaceuticals Inc. PRAECIS PHARMACEUTICALS INCORPORATED Receives FDA Approval for Plenaxis. Media Release : 25 Nov 2003. Available from: URL: http://www.praecis.com 809028616 1 Inpharma 6 Dec 2003 No. 1416 1173-8324/10/1416-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: Gonadotropin releasing hormone antagonist, Plenaxis, receives US FDA approval

Inpharma 1416 - 6 Dec 2003

■ The US FDA has approved an injectablesuspension of the gonadotropin releasing hormoneantagonist, abarelix [Plenaxis; PraecisPharmaceuticals]. Plenaxis, the first gonadotropinreleasing hormone antagonist available as a depotformulation, is indicated for the palliative treatment ofmen with advanced symptomatic prostate cancer, inwhom LHRH agonist therapy is not appropriate andwho refuse surgical castration, and have one or moreof the following: risk of neurological compromise dueto metastases; ureteral or bladder outlet obstructiondue to local encroachment or metastatic disease; orsevere bone pain from skeletal metastases persistingon narcotic analgesia.Praecis Pharmaceuticals Inc. PRAECIS PHARMACEUTICALSINCORPORATED Receives FDA Approval for Plenaxis. Media Release : 25Nov 2003. Available from: URL: http://www.praecis.com 809028616

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Inpharma 6 Dec 2003 No. 14161173-8324/10/1416-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved