Pharmacia Dynastat resubmission
Executive Summary
Pharmacia will resubmit an NDA for COX-2 inhibitor Dynastat (parecoxib) in 2003, Exec VP and President-Research & Development Goran Ando tells analysts at the SG Cowen healthcare conference in Boston March 12. "We will do more multiple efficacy and safety studies" for parecoxib "where the patients typically have pain for several days" because "we have the same questions from the FDA as we had with Bextra," the company's follow-on COX-2 to Celebrex, he said. Parecoxib received a "non-approvable" letter in July 2001...