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Firm Finishes Smallpox Vaccine License Application

Global Security Newswire

British drug maker Acambis PLC said it has completed its application for a U.S. license to market its smallpox vaccine, AFX reported today (see GSN, Jan. 4).

The company in January began submitting the application on a rolling basis to the Food and Drug Administration. It includes information from clinical trials on the drug’s safety, tolerability and effectiveness.

The agency in 2004 gave the drug “fast-track” status, AFX reported. Company CEO Gordon Cameron said he expects the FDA review of the drug to be finished this year.
Acambis is making the vaccine for the United States and other countries. It is also working on an attenuated smallpox vaccine (AFX/Forbes.com, April 18).