FDA approves accelerated dosing schedule for GSK's Twinrix

8 April 2007

UK drug major GlaxoSmithKline says that the US Food and Drug Administration has approved Twinrix (inactivated hepatitis A vaccine and hepatitis B recombinant vaccine) in an accelerated dosing schedule that consists of three doses given within three weeks, followed by a booster dose at 12 months. The approval means the agent, the only hepatitis A and hepatitis B combination vaccine approved in the USA, is now available on a dosing schedule at 0, seven and 21-30 days, followed by a booster dose at 12 months. The vaccine was first approved for adults over the age of 18 years by the FDA in May 2001 on a 0, one and six-month schedule.

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