Market Update On Fondaparinux
Alchemia, Brisbane, Australia (ASX: ACL) has been made aware that the Canadian generic company, Apotex, has launched an Authorized Generic (AG) version of GlaxoSmithKline's drug Arixtra (fondaparinux sodium). Whilst there has been no official announcement regarding an AG from either Apotex or GSK, according to the Apotex website, the AG was launched on 2nd August 2011.
As the AG of Arixtra, Apotex is expected to sell the branded fondaparinux product, which is manufactured by GlaxoSmithKline, as a generic.
Commenting on the development, Alchemia's CEO, Pete Smith said "it is not uncommon for a branded drug manufacturer to launch an AG through a third party. At this stage we have no information on the extent of likely competition or whether the AG has entered or, indeed, will enter the market."
Authorized generics are drugs that are approved by the Food and Drug Administration ("FDA") as brand-name drugs, but where the brand owner subsequently chooses to market (or have marketed) a generic version in addition to its brand-name drug. The packaging typically is different to the brand-name drug but the drug products are chemically identical. Because the AG is produced under the existing NDA of the branded drug manufacturer, the AG does not need a separate approval through the ANDA route, as any other potential competing products would.
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