Sanofi pulls European and other regulatory filings for Mulsevo
The European Medicines Agency says it has been formally notified by French drug major Sanofi (Euronext: SAN) of its decision to withdraw its application for a centralized marketing authorization for its Mulsevo (semuloparin sodium), 20mg, solution for injection, which was intended to be used for the primary prophylaxis of venous thromboembolism (VTE) in cancer patients receiving chemotherapy for locally-advanced or metastatic solid tumors.
The application for the MA for Mulsevo was submitted to the EMA on September 29, 2011. At the time of the withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP). In its withdrawal letter, the company stated that it has decided to withdraw all applications globally following comments by regulatory agencies.
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