GlaxoSmithKline blocks generic Flixonase sales

GSK has obtained a temporary injunction against the US generic versions of nasal spray Flixonase.

The US Food and Drug Administration (FDA) had approved a generic form of the drug produced by Roxane Laboratories. GSK’s injunction, granted by a Baltimore federal judge, will block Roxane’s generic and others from being shipped and sold, including a version by Par Pharmaceuticals which GSK had authorised.

The drugs giant argued that the FDA had used a different set of quality standards in assessing Flixonsae to that used for the generic. It is thought that hearings into the case will continue following the expiry of the restraining order on March 6th.

In a statement generic manufacturer Par responded that it had “halted all shipments of fluticasone propionate nasal spray and will take other steps necessary to comply with this order”.

Flixonsae is one of GSKs biggest selling treatments, with revenues from the drug topping $1 billion (?575 million) per year. It is used to treat chronic runny nose conditions in both children and adults.

The FDA told Reuters that it could not comment on future legal action against it.

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