www.fdanews.com/articles/81269-praecis-pharmaceuticals-incorporated-announces-german-regulatory-approval-for-plenaxis
PRAECIS PHARMACEUTICALS INCORPORATED ANNOUNCES GERMAN REGULATORY APPROVAL FOR PLENAXIS
September 29, 2005
PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS) today announced that it has received marketing authorization for Plenaxis(R) (abarelix 100 mg powder for an injectable suspension) from the German competent authority, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM). In Germany, Plenaxis(R) is indicated to initiate hormonal castration in patients with advanced or metastatic, hormone-dependent prostate cancer, if androgen suppression is appropriate.
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