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Hikma's generic Advair faces U.S. delay, 2017 approval unlikely

Reuters - UK Focus

LONDON, May 11 (Reuters) - Hikma Pharmaceuticals (Frankfurt: A0HG69 - news) said on Thursday that U.S. regulators had decided not to approve its generic copy of GlaxoSmithKline (Other OTC: GLAXF - news) 's blockbuster lung drug Advair at this time, due to 'major' issues with its application.

The company said there was a low likelihood of approval this year.

Hikma and its partner Vectura are in a race with Mylan (Hamburg: 27249935.HM - news) to bring the first substitutable generic version of Advair to the U.S. market. The U.S. Food and Drug Administration has already delayed approval of Mylan's generic. (Reporting by Ben Hirschler)