London-based GlaxoSmithKline won U.S. approval to sell its vaccine to fight H1N1 influenza, also known as swine flu, after an eight-week delay.
The Food and Drug Administration cleared the vaccine as a strain change to Glaxo's FluLaval seasonal flu vaccine, the drug maker said Tuesday in an e-mailed statement.
The U.S. Health and Human Services Department has ordered 7.6 million doses of the swine flu vaccine as part of about 250 million doses secured from all manufacturers, the company said.
Although swine flu vaccines made by AstraZeneca, CSL Ltd., Novartis and Sanofi-Aventis were cleared for sale by the FDA on Sept. 15, Glaxo was left out because of challenges making a vaccine without an adjuvant, an ingredient added to boost potency so more people can be treated. U.S. officials decided not to use adjuvants in their immunization program.