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Hikma Pharmaceuticals says generic Vascepa approved by US FDA

In London, Hikma shares rose by 38p or 1.51% to change hands at 2,551.49p.

Hikma Pharmaceuticals plc. - Hikma Pharmaceuticals’s generic Vascepa approved by US FDA

Hikma Pharmaceuticals Plc (LON:HIK) told investors that its US subsidiary has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsules, 1 gm, as the generic equivalent to Vascepa.

It comes after the United States District Court for the District of Nevada invalidated six key Vascepa® patents owned by Amarin. That decision is being appealed.

“The approval for our generic version of Vascepa® is an important milestone towards bringing this product to market,” said Brian Hoffmann, Hikma’s president of generics.

“This approval demonstrates the strength of our regulatory capabilities and our commitment to provide patients and healthcare providers in the US with the high-quality medicines they need."

Quick facts: Hikma Pharmaceuticals PLC

Price: 2504 GBX

Market: AIM
Market Cap: £5.78 billion

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