SureClick



SureClick is a trademarked medical device, produced by Amgen and Wyeth Pharmaceuticals. The product is sold pre-filled with drugs from these corporations. The device itself is a needle-based, spring-loaded, plunger (piston)-drive autoinjector (drug delivery device). It is disposable, self-injectable, pen-shaped, and portable. The SureClick autoinjector is available for both Aranesp for anemia and Enbrel for rheumatoid arthritis. A previous product, the Neulasta SureClick injector, was recalled in 2006 due to malfunctions of the injector which failed to dispense the proper dosage.[1][2] All three are classified as "combination product" by FDA; as such, the two remaining on the market are classified in the United States as drug products and not medical devices.[3]
Autoinjectors have been in the market as long as pen injectors in the 1990s (first pen introduced in 1984 for insulin) but their use was restricted to emergency medical technicians. Reusable autoinjectors have been used since the 1990s for syringe-based hormone replacement. In 2005 the European Union approved SureClick with Aranesp for chemotherapy-induced anemia (half-million used by Sept. 2006). In June 2006, FDA cleared SureClick autoinjector for Enbrel[4] and in September 2006 the FDA cleared use of SureClick for Aranesp.[5]

The evolution of SureClick came about with the introduction of Enbrel in November 1988 in a lyophilized vial configuration with a 50-step mixing and administration procedure; in October 2003 this was greatly improved with a vial adapter; further improvement was realized in November 2004 with pre-filled syringes; until finally in July 2006 the Enbrel SureClick autoinjector was introduced.
From Wikipedia, the free encyclopedia
Jump to: navigation, search

Download More >>>