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FDA Licenses GSK’s H1N1 Vaccine, Last of the Five US Suppliers to be Approved

By Pharmaceutical Processing | November 11, 2009

The FDA has finally approved GlaxoSmithKline’s H1N1 vaccine. GSK is the last of five manufacturers supplying vaccine to the United States to receive approval for its pandemic product. The four other companies received approval for their products in mid-September and the reason for the delay in granting the GSK licence has not been made public. The GSK product is made at the company’s plant in Quebec, which is also making Canada’s pandemic vaccine. Canada is purchasing vaccine with adjuvant, but the U.S. is using only adjuvant-free vaccine. Other U.S. suppliers are Sanofi Pasteur, MedImmune, CSL and Novartis.

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