Hikma says colchicine regulatory approval upheld in US Court of Appeals

Hikma Pharmaceuticals on Thursday said the regulatory approval of its gout medication colchicine has been upheld.

The US Court of Appeals for the District of Columbia Circuit affirmed an earlier decision of the US District Court for the District of Columbia, finding in favour of the US Food and Drug Administration (FDA) and Hikma.

HIkma said the decision means it may continue marketing colchicine 0.6 mg capsules under the brand of Mitigareas well as its authorised generic.

Sales of colchicine in the US were about $651m for the 12 months ending May 2016, according to IMS Health.

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