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GlaxoSmithKline

This article was originally published in The Gray Sheet

Executive Summary

Shipments of Infanrix vaccine in prefilled Tip-Lok syringes begin April 3 following FDA approval via biologics license application supplement. The combination of diphtheria and tetanus toxoids and pertussis antigen vaccine was originally approved in January 1997. The Tip-Lok syringe is manufactured by BD Corp. and filled by GSK. The device is OSHA-compliant for "convenient and time-saving delivery," GSK says. The drug firm also offers Engerix, Havrix and Twinrix vaccines in the Tip-Lok device...

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