LONDON (Alliance News) - Drugmaker Hikma Pharmaceuticals PLC said on Thursday US regulatory approval of the company's Colchicine gout treatment was upheld.
The United States Court of Appeals for the District of Columbia Circuit affirmed an earlier decision of the United States District Court for the District of Columbia, finding Hikma in favour. The Food and Drug Administration's regulatory approval of Hikma's Colchicine 0.6 mg capsule was upheld.
Hikma can now continue marketing Colchicine capsules, used to prevent flares of gout, under the brand name Mitigare, as well as its authorised generic.
According to IMS Health Ltd, sales of Colchicine in the US market were approximately USD651 million for the 12 months ending May 2016.
"I am very pleased that Hikma can continue marketing its colchicine products in the US market," said Samih Darwazah, chairman and chief executive of Hikma.
By Lucy Heming; lucyheming@alliancenews.com
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Hikma Pharmaceuticals (HIK)