Centocor Ortho Biotech Items withdraws NDA for trabectedin for treatment of women with ROC Centocor Ortho Biotech Items, L.P ?online ., today announced that it has voluntarily withdrawn the New Drug Program for trabectedin for the treatment of women with recurrent ovarian tumor .S. Food and Drug Administration’s recommendation an additional Phase 3 research be conducted to obtain approval. In November The NDA was submitted to the FDA, 2008. The ongoing company is evaluating the development program for YONDELIS in recurrent ovarian cancer. Ortho Biotech Oncology Study & Development, device of Johnson & Johnson Pharmaceutical Analysis & Development, L.L.C., recently initiated a Phase 3 study with trabectedin for metastatic L-sarcoma ..
PPD Inc., a leading global contract research company, provides been appointed to conduct the scholarly study. Dr. Bardur Sigurgeirsson, Section of Dermatology, University of Iceland, the Principal Investigator for Europe added, I am delighted to be engaged in the trial of the innovative new product, that i believe to be a significant progress in this therapy region. Related StoriesRXI-109 use after scar revision surgery has beneficial influence on suppression of hypertrophic scarringRXi Pharmaceuticals begins Phase 1/2 scientific trial in ophthalmologyResearchers successfully repair nerve cell damage in Alzheimer's dementiaJohn Mayo and Stephen Evans Freke, Managing General Partners, Celtic Pharma said: We are delighted to advance to Stage III clinical advancement of TDT 067, where we anticipate confirmation that this is a medically and commercially important advance in the treating this common disease.