Generic 'Prilosec' delayed by FDA on AstraZeneca concerns
05 October 2001 19:54 [Source: ICIS news]
HOUSTON (CNI)--The US Food and Drug Administration (FDA) is delaying final marketing approval of Andrx's abbreviated new drug application (ANDA) for a generic version of ulcer drug Prilosec (omeprazole), Andrx said Friday.
Andrx said the delay is because of concerns by pharmaceutical giant AstraZeneca and aaiPharma, which holds patents relating to it.
Officials said AstraZeneca has complained the generic version does not have exactly the same chemical structure as Prilosec.
Prilosec is AstraZeneca's biggest-selling drug but is facing competition from generic drug firms. The Anglo-Swedish pharmaceuticals group has been embroiled in numerous legal challenges to generic firms seeking to launch cheap versions of the medicine. AstraZeneca's patent protection for Prilosec expired Friday.
Andrx said it had anticipated receiving final marketing approval of its tentatively approved ANDA for certain strengths of Prilosec on or shortly after 5 October.
Andrx did not return telephone calls seeking comment.
In a statement, however, Andrx President Elliot Hahn said AstraZeneca and aaiPharma and others in the pharmaceutical industry "are now suggesting by innuendo to the FDA that certain concerns may exist with regard to generic products, but not to their own."
He added: "Andrx is firm in its belief that these latest moves are merely transparent ploys to prevent or delay introduction of generics. We are confident that the FDA, Congress and consumers will quickly see through these latest smokescreens."
Andrx of Fort Lauderdale, Florida is a specialty pharmaceutical company engaged in the formulation and commercialisation of oral controlled-release generic and brand pharmaceuticals utilising its proprietary drug delivery
By: Mike Sheridan
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