Sanofi-Synthelabo Tirapazamine NDA Expected In 2003; ADSs Traded On NYSE
Sanofi-Synthelabo expects to file a tirapazamine NDA in late 2003 for the treatment of non-small cell lung cancer, the company said in a 1registration statement filed with the Securities & Exchange Commission
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Advair for COPD: GSK hopes to receive approval of Advair (fluticasone/salmeterol) for chronic obstructive pulmonary disease in "a few months," CEO J.P. Garnier tells April 24 conference call. Although an FDA advisory committee "was unabashedly in favor" of the new indication, the agency "asked us for some data and we have now supplied the data.... I don't expect this to come to a fast resolution." FDA approved only the NDA for salmeterol (Serevent) for the COPD claim (1"The Pink Sheet" April 1, p. 27)....Off-label use likely: While the Advair COPD indication has hit a snag at FDA, "there is use in the medical community," Garnier notes. "This is not encouraged. It just happens with specialists who have experience with Advair in COPD. We're getting good reports. We're trying to manage this as best we can"...
Organon and Sanofi-Synthelabo will launch the injectable antithrombotic Arixtra with 240 sales reps in late January
Studies showing an overall survival advantage for Sanofi-Synthelabo's Eloxatine over 5-FU-based chemotherapy would be needed for approval of the agent as first-line therapy for colorectal cancer, FDA's Oncologic Drugs Advisory Committee found March 16.