Sanofi Pulls Global Filings For Semuloparin As VTE Prophylaxis In Cancer Patients
This article was originally published in The Pink Sheet Daily
Executive Summary
The company decided to withdraw all applications for approval of the low molecular weight heparin following comments from regulatory agencies. FDA and its Oncologic Drugs Advisory Committee had taken a negative view of the semuloparin NDA, believing Sanofi failed to identify an appropriate population of chemotherapy patients.